FDA
28th July 2018

FDA Advisory Committee Against Extended Release Oxycodone Capsules

On June 26th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety.

FDA Advisory Committee Against Extended Release Oxycodone Capsules

On June 26th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee reviewed New Drug Application (NDA) 022324 for extended release oxycodone capsules (Remoxy ER) by Pain Therapeutics Inc.

Remoxy ER is an abuse deterrent, pain relief medication for those with severe enough pain to require constant, long term opioid treatment. According to the CDC, there were more than 64,000 opioid overdose deaths in 2016. Pain Therapeutics developed a new Abuse-Deterrent Formulation (ADF) for oxycodone ER capsules in an effort to combat the problem.  Remoxy ER is intended to be taken once every 12 hours.

The sponsor indicated that Remoxy ER is produced with a high viscosity formulation that does not flow, making it difficult to snort, syringe or inject into one’s body.  The sponsor also claimed that attempting to smoke this drug will release vapors that irritate the lungs and eyes, while the active ingredient degrades.

However, studies conducted by an independent lab did not support either case. An independent smoking study showed significantly more carbonized oxycodone with Remoxy ER that OxyContin ER. Overall, the drugs deterrent properties are supported by data from FDA Categories 1 through 3 studies.

The panels voted 14 to 3 against the approval of Remoxy ER. The agency is not obligated to follow its panel’s recommendation, but normally does so.

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

This post was authored by Sami Mourad. Sami is a summer intern at ISS and a 3rd year pharmacy student at the Rutgers University Ernest Mario School of Pharmacy.

Do you have an upcoming Advisory Committee Meeting?

  • This field is for validation purposes and should be left unchanged.

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us