During this meeting on Tuesday, April 22, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) discussed the safety.
During this meeting on Tuesday, April 22, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) discussed the safety and efficacy for the new drug application (NDA) 203077, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, submitted by QRx Pharmaceuticals Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. Moxduo is a fixed-ratio, immediate-release combination of morphine sulfate and oxycodone hydrochloride. It represents the first drug combination consisting of two immediate-release opioids.
In this meeting, there were two discussion questions and two voting questions. The panel voted unanimously against approval for the drug for the treatment of acute pain. Additionally, the panel voted unanimously that Moxduo was not safer than morphine and oxycodone given the available safety data.
The vote relied primarily on the results from “study 022”. This trial involved 375 patients with moderate to severe acute pain after bunionectomy. Its primary endpoint was oxygen desaturation (SpO2 <90% for at least 16 continuous seconds) as respiratory depression is most often the cause of death from opioid overdose.
Randall Flick, MD, MPH, the AADPAC chairperson, noted that “the Applicant has not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone.” Dr. Flick added that the “primary failing” was in study design and the inability of the committee to be able to rely “with confidence” on multiple post-hoc analyses that were performed by QRx Pharmaceuticals. Additionally, many panelists highlighted the fact that Moxduo has a strong potential for abuse, similar to its competitors.
The agency is not obligated to follow its panel’s recommendation, but normally does so.
ISS has over a decade 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 email@example.com
Do you want a more detailed analysis of this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a detailed post-meeting outcome report!
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
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
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
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
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 todayContact us