Author Archives: Mark Ilhan
When choosing a company to manufacture your pharmaceuticals, there are so many different aspects to consider. Aside from the bottom-line pricing, product safety and quality are the biggest drivers of deciding whether to contract with a manufacturing company.
The FDA’s regulations offer a systematic framework for companies to follow to ensure that their products are of the highest quality and safety. The FDA warning letters companies might receive are then a result of inspections and any noncompliance with established standards. Over the years, more warning letters have been issued because an aging American population and an increasing need to address chronic diseases has prompted growth in research and development in pharmaceuticals and medical technologies.
Before the addition of the Quality System Regulations in 1997, the FDA found that about 44% of quality issues leading to voluntary recall actions were attributed to deficiencies in product design that would have been prevented with better controls. The general trend has been an increase in violations in design control which shows increasing FDA’s emphasis on it. The quality systems fall in five categories:
- Production and process controls – Production and process controls relate to establishing and maintaining procedures to document, monitor, and verify compliance of the manufacture of the product. These processes are applied to all phases of production beginning with initial purchase and receipt of raw materials and/or parts and extending to the sale, distribution, installation, and servicing of the finished product.
- Corrective and preventive actions – CAPAs relate to establishing and maintaining procedures for investigating non-conformances, identifying actions to address these, and verifying that these actions are effective.
- Design controls – Design controls involve the establishment and maintenance of procedures to control the design of the device to ensure that the specified design requirements are met.
- Management controls – Management controls refer to policies, organizational structure, resources, personnel, and internal review of the quality system.
- Document controls – Document controls relate to procedures for documenting device and batch-/lot-specific specifications and production processes, as well as those for document approval, distribution, and changes.
The Difference Between Form 483 and a Warning Letter
After an inspection, the FDA usually issues Form 483, which details inspectional observations. The form is used as a guide for voluntary corrective action with a response from the company required within 15 working days.
It is not a final determination of whether the business is in violation of any regulations. On the other hand, a warning letter states the exact regulation of which the company is in violation. The warning letter has the potential to have an impact on requests by the company for certain licenses or applications. The FDA can also take legal action if the concerns in the letter are not addressed.
The Most Common Warning Letter – Failure to Follow Standard Operating Procedures (SOPs)
Just like any other organization, the FDA has limited resources. This means that when they inspect a company, one of the biggest aspects they focus on is the standard operating procedures because the foundation of the quality system is a set of SOPs that are meant to be followed to ensure compliance with regulations. The consensus is that if a company does not take compliance with SOPs seriously, they will not take other regulatory compliance seriously either.
Why Oakwood Labs Is the Best Choice for a CDMO Partner
Oakwood Labs maintains rigorous in-house quality systems, including Quality Assurance and Validation, QC Microbiology, and QC Chemistry. Our team is highly committed to quality and has a long history of compliance.
Quality Assurance/Validation
We have a documented Quality Management System (QMS) designed and implemented to fulfill the following regulatory requirements:
- FDA 21 CFR Part 210 and 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals
- FDA 21 CFR Part 4, Regulation of Combination Products
- FDA 21 CFR Part 11 Electronic Records and Electronic Signatures
- ICH Q10 Pharmaceutical Quality System
Need a Trusted Partner for FDA Compliance? Contact Us
If you want to ensure that your operations avoid running afoul of the FDA, let the experts at Oakwood Labs help. Reach out to our team today to discuss project details and we can get to work developing workable solutions.
Because of opioids’ abilities at treating moderate to severe pain, acute pain, and chronic pain, as well as their use in other roles, many doctors and medical facilities rely on them to provide patients with the best care possible for a range of conditions. While there are several ways to distribute opioids, one viable approach is using long-acting injectables, or LAIs, to achieve reliable and precise results.
At Oakwood Labs, we’re experts at long-acting injectable development for an array of medicine types, including opioids. Read on to learn about everything we can provide and why we’re the right choice for opioid medication development.
Uses and Forms of Long-Acting Injectable Opioids
Medical professionals may opt for long-acting injectables for opioid administration due to the many benefits the approach provides, or in some cases they may rely on LAIs when other methods are nonviable or unable to treat ongoing conditions effectively.
Specific applications can include distribution of:
- Medications for moderate to severe pain
- Medications for acute pain
- Medications for chronic pain
- Sedatives
- Anesthesia
Some of the opioids that have been successfully produced as extended-release medications include:
- Avinza
- Kadian
- MS Contin
- Exalgo
- Duragesic
- Dolophine
- Butrans
- Embeda
- Nucynta ER
- OxyContin
- Palladone
- Opana ER
- Fentanyl (generic)
- Methadone hydrochloride (generic)
- Morphine sulfate (generic)
- Oxymorphone hydrochloride (generic)
Benefits of Using LAIs for Opioid Administration
There are a variety of advantages to using long-acting injectables for opioids and other drugs, including:
- Reduced injections and less frequent doses – Patients need to receive injections only every few weeks or months, depending on the circumstances, compared to other application methods that may require daily use
- Prevention of drug abuse – Since opioids have the potential for abuse and addiction, using long-acting injectables for administration over other methods keeps the control in health professionals’ hands, preventing intentional or accidental abuse
- Improved adherence – With a regular injection schedule, patients will be less inclined to miss or forget doses, allowing them to stay on track and fully benefit from their treatment plan
- Consistent dosing – LAIs provide a steady dose of a drug over time, minimizing the peaks and valleys that can come about from daily oral medications
Long-Acting Injectable Development at Oakwood Labs
The Oakwood Labs long-acting injectable development process uses our technology platform Chroniject™. Some of the benefits of the Chroniject™ system and our overall LAI approach include:
- Medication release durations of 1 week to 1 year
- Formulations that are easy to scale
- Rapid development of formulations via small-scale batches
- Excellent stability characteristics
- Proven content uniformity
- Molecule compatibility with small molecules, proteins, and peptides
- Absence of foreign particulate matter
- Immediate reconstitution with WFI, and no special diluents are required
- Well-controlled process parameters
- Proven lot-to-lot reproducibility
- Ease of syringe administration with 18- to 23-gauge needles
Other Long-Acting Injectable Opportunities for Opioids
In addition to supplying LAIs for opioid drugs, our team is also adept at providing extended-release solutions for treating opioid use disorder. Though opioids have many uses for patient care, they can obviously be abused or lead to accidental addiction.
Just as LAIs excel at controlling opioid distribution, they can also help healthcare providers and patients treat addiction. If your organization is interested in this additional long-acting injectable application, know that you can benefit by way of:
- Removing the need for daily dosing, reducing the chance of missed doses and patient relapses
- Targeting specific areas of the body, particularly the brain, which affects withdrawal symptoms, cravings, and euphoric effects
- Ensuring consistent medication levels that can lead to improved patient outcomes
Contact Us for Opioid Long-Acting Injectables
The Oakwood Labs team is ready to provide your organization with the long-acting injection solutions you need to supply first-rate medical care. Reach out to our team today to discuss options.
Oakwood Labs is happy to announce that we will be participating and presenting at the upcoming Forum on Pharma: Building Better Injectables. The event goes from June 3-5 at the Ashland R&D site in Wilmington, Delaware. If you would like to learn more about the event, please visit the following link: https://solving.ashland.com/pharmaceutical/wilmington-injectable-form-0632025
Company Overview
Oakwood Labs is a global leader in sustained release drug delivery. We support all phases of long acting injectable development from initial feasibility studies through FDA-approved clinical and commercial supply. Oakwood has 28 years of drug encapsulation experience using Chroniject™, our patented microsphere-based technology. Chroniject™ provides the ability to control particle size, customize release durations from weeks to years, and minimize residual solvents to achieve critical quality attributes.
Oakwood will be presenting:
Dr. Tracy Richey (Senior Director of Technology) will be presenting on understanding advanced delivery formulation techniques.
Contact Us for More Information
The Forum on Pharma covers a wide range of topics, and we are happy to contribute to the event! If you aren’t able to attend, but still want to learn more about Oakwood Labs or what you missed at the conference, contact us today!
We look forward to discussing our technology and more.
Oakwood Labs is happy to announce that we will be exhibiting at Booth #748 at the upcoming 2025 Convention on Pharmaceutical Ingredients (CPHI) on May 20-22 in Philadelphia, Pennsylvania. If you would like to learn more about the event and register to attend, please visit the following link: https://www.cphi.com/americas/en/home.html
Company Overview
Oakwood Labs is a global leader in sustained release drug delivery. We support all phases of long acting injectable development from initial feasibility studies through FDA-approved clinical and commercial supply. Oakwood has 28 years of drug encapsulation experience using Chroniject™, our patented microsphere-based technology. Chroniject™ provides the ability to control particle size, customize release durations from weeks to years, and minimize residual solvents to achieve critical quality attributes.
Stop by Oakwood Lab’s Booth #748 to meet our team and learn more about how we can assist in the following areas:
- Long Acting Injectable Technology (CDMO)
- Feasibility studies
- Scale-up and optimization of formulation
- Manufacturing GLP toxicology batches
- Clinical trial manufacturing (Phase I, II, III)
- Contract Manufacturing (CMO)
- Technology Transfer
- GMP Registration and Validation batches
- Aseptic GMP commercial batch manufacturing
- ICH compliant stability testing
Contact Us for More Information
The CPHI Americas 2025 conference covers a wide range of topics, and we are happy to contribute to the event! If you aren’t able to attend, but still want to learn more about Oakwood Labs or what you missed at the conference, contact us today!
We look forward to discussing our technology and more.
Oakwood Labs is happy to announce that we will be exhibiting at Booth #2030 at the upcoming 2025 Association for Research in Vision and Ophthalmology (ARVO) on May 4-7 in Salt Lake City, Utah. If you would like to learn more about the event and register to attend, please visit the following link: https://www.arvo.org/annual-meeting/
Company Overview
Oakwood Labs is a global leader in sustained release drug delivery. We support all phases of long acting injectable development from initial feasibility studies through FDA-approved clinical and commercial supply. Oakwood has 27 years of drug encapsulation experience using Chroniject™, our patented microsphere-based technology. Chroniject™ provides the ability to control particle size, customize release durations from weeks to years, and minimize residual solvents to achieve critical quality attributes.
Stop by Oakwood Lab’s Booth #2030 to meet our team and learn more about how we can assist in the following areas:
- Long Acting Injectable Technology (CDMO)
- Feasibility studies
- Scale-up of formulation
- Manufacturing toxicology batches
- Clinical trial manufacturing (Phase I, II, III)
- Contract Manufacturing (CMO)
- Technology Transfer
- GMP Registration and Validation batches
- Aseptic GMP commercial batch manufacturing
- ICH compliant stability testing
Contact Us for More Information
The ARVO 2025 conference covers a wide range of topics, and we are happy to contribute to the event! If you aren’t able to attend, but still want to learn more about Oakwood Labs or what you missed at the conference, contact us today!
We look forward to discussing our technology and more.
The pharmaceutical industry harbors a vast range of key facts and significant data that can be beneficial to individuals and companies in the field. With the pharmaceutical market on a continuous rise in terms of revenue, innovation, and research, it’s important to stay up to date on current trends.
That’s why our team has compiled a list of 40+ statistics for your review, so you can learn more about the thriving pharmaceutical sector.
General Pharmaceutical Industry Trends
- New modalities, like cell and gene therapy, have increased from 11% to 21% of the drug development pipeline (McKinsey & Company)
- Based on pharmaceutical sales, the top therapeutic areas in the pharma industry are antidiabetics, immunology, oncologics, HIV antivirals, and respiratory (Statista)
- Research and development spending reached more than 300 billion dollars in the United States in 2023 (Statista)
- In 2023, biotechnology contributed to 40% of global pharmaceutical sales (Statista)
- The process of developing a new drug costs around 2.6 billion dollars in the USA, with the drug taking an average of 15 years to develop (Statista)
- The Pharmaceutical Research and Manufacturers of America trade group spends 21% of their revenue on research and development (Statista)
- PhRMA member companies spent 96 billion dollars in the USA on research and development in 2023 (Statista)
- In 2023, more than 5,500 pharmaceutical companies were conducting active research and development (Statista)
- More than 21,000 drugs were in the research and development phases in 2023 due to COVID-19 responses (Statista)
- Pfizer was the top U.S. company to develop new drugs in 2024 (Statista)
Statistics About the Pharmaceutical Market
- The total global pharmaceutical market in 2023 was estimated at around $1.6 trillion (Statistica)
- Compared to 2022, the total global pharmaceutical market increased by over 100 billion dollars in 2023 (Statistica)
- The United States accounts for nearly 40% of the world’s pharmaceutical market (National Library of Medicine)
- As of 2023, the top 5 largest pharmaceutical companies were Eli Lilly ($578.3B), Novo Nordisk ($452.8B), Johnson & Johnson ($377.7B), Merck ($263.9B), and AbbVie ($261.2B) (Visual Capitalist)
- Approximately $60 billion is spent collectively by the top 20 pharmaceutical companies each year for drug development (McKinsey & Company)
- The United States accounts for roughly 50% of global pharmaceutical sales revenue (PharmaNewsIntelligence)
- The pharmaceutical market in the United States is expected to surpass $1 trillion by the year 2030 (American Pharmaceutical Review)
- The biopharmaceutical market is expected to reach nearly $517 billion in 2024, and reach up to almost $762 billion by 2029 (Modor Intelligence)
- From 2024 to 2028, the pharmaceutical market is projected to experience an increased annual growth rate of 5.96% (Statistica)
- By 2027, the total global spending on medicine is projected to reach $1.92 trillion (Statistica)
- Currently, the United States is looking for an increased demand for personalized medicine and more targeted therapies (Statistica)
- In 2024, the United States gained more than 760 billion dollars in revenue from the pharmaceutical market (Statista)
- The United States accounted for 52% of global sales in the global pharmaceutical sector in 2024 (Statista)
A Career in the Pharmaceutical Industry: Noteworthy Statistics
- 56.8% of pharmacists in the United States are women and 43.2% of pharmacists are men (Zippia)
- Approximately 1.3 million people are employed in the pharmaceutical industry in the United States (U.S. Bureau of Labor Statistics)
- The average age of a pharmacist is 41 years old (Zippia)
- 91% of graduated pharmacists are known to work in the private sector (NIH)
- The average salary of a pharmacist is $118,968 as of 2024 (Zippia)
- The highest paying state for pharmacists is California, where the average yearly salary is $161,597 (Zippia)
- For every dollar that a man makes as a pharmacist, a woman makes approximately 98¢ (Zippia)
- The employment for pharmacists is expected to grow by 3% from 2022 to 2032 (U.S. Bureau of Labor Statistics)
- Over the decade, there is said to be 13,400 openings for pharmacists projected each year (U.S. Bureau of Labor Statistics)
- There has been a 20% increase in the demand for STEM-related jobs, making it difficult for the pharma industry to recruit technical talent (McKinsey & Company)
Statistics on Popular Prescription Drugs
- According to the Centers for Medicare & Medicaid Services (CMS), out-of-pocket drug spending is projected to peak in 2023 at $52.5 billion (Peterson-KFF)
- As of July of 2023, 25% of adults who take prescription drugs report difficulty in affording their medication (Peterson-KFF)
- There are more than 32,000 generic drugs that are approved by the FDA as of 2022 (FDA)
- In the United States, 91% of prescriptions are filled as generic drugs (FDA)
- Nationwide, the total spending on prescription drugs increased from $30 billion in 1980 to $335 billion in 2018 (Congressional Budget Office)
- Though the top 10% of drugs by price account for less than 1% of all prescriptions, they make up 15% of the retail spending and anywhere from 20% to 25% of the nonretail spending (ASPE)
- In 2020, around 6.3 billion prescriptions were dispensed in the United States (Statistica)
Oakwood Labs: Innovator of Sustained Release Drugs for the Pharmaceutical Sector
As seen in these compelling pharma market insights, it’s clear that the pharmaceutical industry is continuing to expand and develop, providing great value for both patients and business alike. Oakwood Labs plays an important role in this growth as a leader in the design and development of sustained-release drugs.
By using Chroniject™ technology, we developed a process where small molecules, peptides, and proteins can be injected and released over weeks, months, or years. This technology supports innovative solutions and has contributed to the success of the pharma industry.
With over 25 years of experience, we’ve helped bring drugs to the pharmaceutical market that enhance patient care and greatly benefit organizations. We also work with a wide range of clients, supplying services such as:
- Analytical and stability testing
- GMP aseptic manufacturing
- Feasibility program
- Formulation optimization and scale-up
- Contract manufacturing
By staying up to date on current pharma market insights, Oakwood Labs can help deliver the pharmaceutical solutions you’re looking for.
Contact Oakwood Labs for More Information
Oakwood Labs is a global provider of sustained-release pharmaceuticals and other medical services. Please contact our team of experts today for more information about all we can provide, as we look forward to answering any inquiries you have.
At Oakwood Labs, we’re dedicated to providing alternative solutions to drug delivery and development. This includes our ongoing work creating long-acting injectables for treating pulmonary arterial hypertension.
For those interested in learning more about the specific strides we’ve made within this sector, as well as the opportunity to partner with us, read on or contact our team today.
Then and Now: A Brief History of Pulmonary Arterial Hypertension Drug Development
The introduction of Epoprostenol in 1995 marked the first true breakthrough in pulmonary arterial hypertension (PAH) treatment, as this medication was able to show the potential to target the prostacyclin pathway. Following this development, individuals began further research into other potential treatment options to help patients suffering from PAH.
It was not until 2001 that the first oral therapy, Bosentan, was approved and released to the public. Since then, 12 additional medications have been approved by the FDA to treat PAH, such as soluble guanylate cyclase (sGC) stimulators, endothelin receptor blockers (ERBs), and phosphodiesterase-5 (PDE-5) inhibitors, to name a few.
Additionally, there are a few current trends in the advancement of pulmonary arterial hypertension pharmaceutical development, including those focused on:
- Combination therapies
- Targeted therapies
- Delivery methods
About Our Work Creating Long-Acting Injectables for Treating Pulmonary Arterial Hypertension
The team at Oakwood Labs has used its advanced technology to create injectables for treating pulmonary arterial hypertension. Though most of the formulations that are currently on the market for PAH treatment are mainly oral medications, the use of LAIs can come with several advantages, such as a decrease in the amount of drug administered to the patient, less frequent doses, and more.
Partner with Oakwood Labs
In order to further develop our cardiology program, Oakwood Labs is looking for an external partner to fulfill the responsibilities of the role. This includes managing phases 1–3 of clinical trials, funding development activities, and helping with ongoing commercialization and registration efforts.
For more information on the details of the position, please reach out to our team directly, as we would be happy to supply you with additional information about the development work to date, market opportunity, and estimated financial projections.
FAQs About Pulmonary Arterial Hypertension LAI Development
What are the major benefits of an LAI in cardiovascular treatments?
Pulmonary arterial hypertension (PAH) is a rare, progressive disease that causes high blood pressure in the arteries of the lungs. Symptoms include shortness of breath, chest pain, and increased heartbeat.
LAI treatments in this area focus on vasodilators and platelet aggregation inhibitors. They work by relaxing blood vessels, including those in the lungs, and improving blood flow.
What are the current barriers to an LAI entering this particular space?
The barriers to entry for the LAI space are very high. You need to have a proven technology capable of delivering the right amount of the drug within a given therapeutic window. Plus, you need an FDA-approved GMP facility to manufacture the product, as well as a high level of expertise to understand, develop, and validate the process.
Oakwood Labs has all of these capabilities and over 25 years of experience within this field.
What sets Oakwood Labs apart from others in the development of LAIs to treat PAH and other cardiovascular issues?
Our team of experts has used its technology to develop formulations focused on treating pulmonary arterial hypertension with a release duration of one month. Current treatments, which mostly focus on oral medications, work in different ways but ultimately attempt to decrease symptom severity and increase exercise capacity.
The use of an LAI product would offer benefits similar to other therapeutic areas including reduction in the total amount of drug administered to the patient, as well as less frequent doses.
Reach Out to Us
If you have any additional questions about our continued work in pulmonary arterial hypertension drug development, or if you’re looking to partner with us, please contact us today.
The team at Oakwood Labs has made it our mission to develop long-acting injectables to treat various diseases and disorders. This includes ongoing work with drugs to treat acromegaly and carcinoid tumors, both rare diseases that affect millions of people globally. Read on to learn more about the strides we’ve taken within endocrinology, and the broader healthcare sector.
The History of Acromegaly and Carcinoid Tumor Drug Development
Though carcinoid syndrome was first described by Thorson and colleagues in 1954, Pierre Marie discovered acromegaly years prior in 1886. At these times, there were no acromegaly and carcinoid tumor pharmaceuticals to reduce the size of malignant or benign growths, so surgical removal of a tumor was incredibly common.
Then, in the 1970s, dopamine agonists, such as bromocriptine and cabergoline, were introduced as treatment options to control tumor growth for acromegaly and carcinoid syndrome. However, the treatment came with a range of side effects, such as nausea, dizziness, and constipation, to name a few, so they are not used as standalone options for treatment today.
The Current State of These Pharmaceuticals
Numerous strides have been made within the healthcare sector since the early stages of acromegaly and carcinoid tumor drug development. For example, as of June 2020, the FDA has approved oral octreotide capsules as one of the first long-term maintenance treatments for acromegaly. This alternative is a viable solution for individuals who have responded to and tolerated treatment with injectable SRLs.
Along with more recent trials and discoveries, several targeted drugs are used to treat these diseases and manage their symptoms, with Sandostatin being one of the most common. These synthetic acromegaly and carcinoid pharmaceuticals are designed to mimic the body’s natural hormone, somatostatin, which, in turn, prevents the body from producing too many growth hormones and serotonin.
What Oakwood Labs Is Developing Internally for Acromegaly and Carcinoid Tumor Treatment
Oakwood Labs has successfully manufactured and scaled up formulations focused on treating acromegaly and carcinoid tumors. The daily injections initially used for these conditions have been largely replaced by Sandostatin LAR, a one-month LAI product. Plus, our two-month formulations further reduce the number of injections and office visits patients experience by 50%, which can also help with enhancing patient compliance.
Additionally, Oakwood Labs currently has two endocrinology programs that are focused on creating pharmaceuticals to treat acromegaly and carcinoid tumors. Project Treestar is designed to specifically treat acromegaly and cancer-related nausea, while Project Lunar is looking to help those with type 2 diabetes.
Partnership Opportunities
Oakwood Labs is seeking an external partner to help further develop our endocrinology program. Just some of the key responsibilities include:
- Funding the ongoing development activities
- Overseeing phase 1-3 of clinical trials
- Contributing to registration and commercialization efforts
If you’re interested in pursuing this opportunity, please reach out to our team directly for more information. We would be happy to supply the partner with additional information about the market opportunity, estimated financial projections, and development work to date.
FAQs About LAIs for Acromegaly and Carcinoid Tumor Treatment
What are the major benefits of an LAI in treatments for acromegaly, carcinoid tumors, and more?
When developing drugs for treating acromegaly and carcinoid tumors, know that long-acting injectables are effective for blocking the production of excess blood levels of growth hormone (GF) and reducing the insulin growth factor-1 (IGF-1) levels in acromegaly patients. This is helpful for individuals who cannot be treated with other methods, such as surgical intervention.
Sandostatin acts as a somatostatin analogue, mimicking a naturally occurring hormone that helps regulate hormone release from the tumor cells. This aids in the treatment of carcinoid tumors.
What are the current barriers to an LAI entering this particular space?
The barriers to entry for the LAI space are very high. You need to have a proven technology capable of delivering the right amount of the drug within a given therapeutic window. You also need an FDA-approved GMP facility to manufacture the product. Finally, you need a high level of expertise to understand, develop, and validate the process.
Oakwood has all these capabilities, along with over 25 years of expertise within the field.
Contact Our Team of Experts Today
If you have any questions regarding the process of developing pharmaceuticals for treating acromegaly and carcinoid tumors, or our work in the endocrinology space, please reach out to our team of experts today. And if you’re looking for a position within our partnership program, contact us directly, as we look forward to hearing from you.
Opioid abuse disorder is very common, affecting over 20 million people worldwide and over 3 million people in the United States. People who misuse opioids may also advance to even more harmful drugs such as heroin, making this a critical issue that needs to be addressed. With the help of long-acting injectables for opioid use disorder pharmaceutical development, new treatment options are now available to patients that are more sustainable.
The History of Opioid Use Pharmaceuticals
The first modern opioid crisis began in the 19th century. During and after the Civil War, this opioid crisis emerged as soldiers were given substances to treat their wounds, pain, PTSD, and depression. As a result, many soldiers developed an opioid addiction. Doctors at this time would give a patient morphine because it was a general cure for all chronic pain problems, but it obviously had negative effects as well.
The opioid crisis dwindled by 1900, and for roughly 90 years opioids were only abused by smaller groups of people. It wasn’t until the early 2000s that the use of opioids once again began affecting communities all over the country. While doctors started to notice the spread of opioids and took steps to curtail it, people were finding other ways to illegally acquire the drugs.
While there are still issues today, we have grown more aware of the risks that are associated with opioid use. There are many efforts being made to hopefully reduce instances of abuse, such as educating those on alternate pain management strategies, developing abuse-deterrent formulations, having stricter prescription guidelines in place, and offering opioid use disorder pharmaceutical development.
Benefits of Long-Acting Injectables for Treating Opioid Use Disorder
Long-acting injectable, or LAI, formulations ensure that patients receive their medications on a regimented schedule. Drugs such as naltrexone and buprenorphine are formulated as monthly injections in order to block the effects of opioids. Initially, these drugs were formulated in daily oral dosages, but LAI products are more effective, as they result in greater patient compliance.
In addition to improved compliance, injectables to treat opioid abuse disorder provide benefits such as:
- Ability to target specific anatomical areas – LAI buprenorphine targets the receptors in the brain, providing effects that help control withdrawal symptoms, reduce cravings, block the euphoric effects of opioids, and maintain stable blood concentrations without peaks.
- Helping to prevent drug abuse – By receiving long-acting injections, patients eliminate the need for daily dosing, reducing the risk of missed doses and relapses.
- Potential for improved outcomes – Injectables help reduce the opportunities for misuse and ensure consistent medication levels are maintained, possibly leading to better outcomes for the patient.
How Oakwood Labs Stands Out
Oakwood Labs has developed 2-, 3-, and 4-month duration prototype formulations of naltrexone, using a different polymer than is used in the 1-month duration naltrexone. We are currently working on scaling up these formulations prior to clinical trials.
We also have a track record of success in bringing other projects from proof of concept to clinical trials, such as proving the duration of release of naltrexone formulations in animal PK models. We are currently seeking partners for clinical development.
By choosing us as a partner in developing injectables to treat opioid use disorder, you’ll benefit from:
- Strong communication and project management that achieves milestones
- Patented microsphere technology that allows tailored release profiles from weeks to one year
- Over 20 years of experience encapsulating sustained-release injectables
- A full-service operation, from R&D formulation development through GMP commercial manufacturing
- An FDA-approved aseptic GMP facility manufacturing clinical and commercial sterile injectables
FAQs on Injectables to Treat Opioid Use Disorder
How do these medications work?
Naltrexone helps block the sedative and euphoric effects of drugs such as codeine, morphine, and heroin. This medication is reported to reduce opioid cravings. Buprenorphine, on the other hand, helps avoid withdrawal symptoms and manage cravings.
What are the current barriers to an LAI entering this particular space?
It is difficult to develop LAI formulations of these drugs, especially for formulations in excess of one month in duration of release. Currently, 1-month duration products have been approved, but no longer than 1-month duration products have been approved yet. Some people are working to develop longer duration products, such as a 2-month duration naltrexone and a 3-month duration buprenorphine. It is generally accepted that longer duration products would be beneficial for patient compliance.
Who are good candidates for injectables?
People who may benefit from injectables for treating opioid use disorder and other conditions include:
- Those who are high-risk, meaning they experience frequent hospitalizations or multiple relapses
- Those who prefer less frequent dosing
- Those who are nonadherent to oral antipsychotics
- Those experiencing dose-dependent adverse effects
- Those who have poor oral absorption
Besides opioid use disorder, what else can LAIs help treat?
Long-acting injectables have been used to treat a variety of conditions such as schizophrenia, bipolar disorder, depression, and more. LAIs have also been used as pharmaceuticals which offer numerous benefits for oncology treatment.
Choose Oakwood Labs for Opioid Abuse Disorder Pharmaceutical Development
If you have an interest in long-acting injectables for treating opioid use disorder, please reach out to us today. We look forward to providing you with more information on how to tackle this ongoing issue in today’s world.
Oakwood Labs will be exhibiting at Booth #31 and speaking at the upcoming 2024 PODD Conference taking place from October 28-29 in Boston. If you would like to learn more about the event and register to attend, please visit the following link: https://poddconference.com/
Company Overview
Oakwood Labs is a global leader in sustained release drug delivery. We support all phases of long acting injectable development from initial feasibility studies through FDA-approved clinical and commercial supply. Oakwood has 27 years of drug encapsulation experience using Chroniject™, our patented microsphere-based technology. Chroniject™ provides the ability to control particle size, customize release durations from weeks to years, and minimize residual solvents to achieve critical quality attributes.
Listen to Oakwood’s presentation during Day 1 on our Chroniject Technology: A Solution to Long Acting Injectable Formulation and Scale-Up Challenges
Colin Spencer, a project manager working within our technology transfer team will be presenting during Day 1 (Monday, October 28th) of the conference within the Track 1A: Injectable Formulations & Technologies at 2:30pm.
The presentation will include the following key points:
- Oakwood’s Chroniject technology provides a tunable long-acting injectable platform for a wide array of molecules and applications. Efficacious release profiles have been generated from as fast as two days to as long as one year.
- Oakwood’s Chroniject technology provides the platform for scale-up of the formulation process, allowing for the critical quality attributes of the long-acting injectable formulations to be maintained from initial feasibility batch sizes in the gram-scale to clinical and commercial batch sizes in the kilogram-scale.
Stop by Oakwood Lab’s Booth #31 to meet our team and learn more about how we can assist in the following areas:
- Long Acting Injectable Patented Technology (CDMO Services)
- Feasibility assessments
- Scale-up and optimization of lead formulation
- Manufacturing, characterization, and stability of R&D toxicology batches
- GMP Clinical trial manufacturing (Phase I, II, III)
- GMP Commercial manufacturing
- Contract Manufacturing (CMO Services)
- Technology Transfer
- GMP Registration and Validation batches
- Aseptic GMP commercial batch manufacturing
- ICH compliant stability testing
Contact Us for More Information
PODD 2024 conference covers a wide range of topics, and we are happy to contribute to the event! If you aren’t able to attend, but still want to learn more about Oakwood Labs or what you missed at the conference, contact us today!
We look forward to discussing our technology and more.