FDA
25th September 2015

FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER

On September 11th, in a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S.

FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER

On September 11th, in a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA), panelists voted unanimously to support the approval of Xtampza ER™ (oxycodone extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Xtampza ER (Collegium) is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. Oxycodone is approved by the FDA and other regulators around the world in a number of both immediate-release and extended-release drug products. According to the Sponsor, Xtampza ER was developed address approximately 11 million people in the U.S. suffering from chronic pain along with difficulty in swallowing. 

The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza ER New Drug Application (NDA).

On the previous day, the two advisory committees convened in order to review and discuss Purdue Pharma’s immediate-release oxycodone (Avridi) application. Panelists voted 23 to 1 against approval due to their main concern around the drug’s requirement to be taken on an empty stomach, which would be too complicated for patients to manage. If these instructions were not followed precisely, it could lead to an increased risk of adverse effects, including overdose.

Panelist Sharon Walsh, PhD, of the University of Kentucky noted, “The problem here is that they have developed something with a beneficial abuse-deterrence property, but the product is inferior to the one on the market from the standpoint of how it will work in the most common patient population that needs it.”

“It might give providers a false sense of safety because it has a label of abuse-deterrence, but in reality it adds a safety concern,” added advisory committee chairperson Almut Winterstein, RPh, PhD, of the University of Florida.

The meeting materials for both meetings can be found HERE. The FDA isn’t required to follow the recommendations of its panels, but it often does.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs 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.

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