Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted tentative approval to Collegium Pharmaceutical's new drug application (NDA) for Xtampza ER (oxycodone), a novel abuse-deterrent analgesic for chronic pain.
Subscribe to our email newsletter
Xtampza ER is an extended-release, oral formulation of oxycodone, in development to manage pain severe enough for daily, long-term opioid treatment and for which alternative treatment options are insufficient.
It has been developed using Collegium’s DETERx technology platform to address common methods of abuse such as chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.
The FDA has determined that Xtampza ER meets all of the required quality, safety and efficacy standards for approval.
However, it is subject to an automatic stay of about 30 months due to a patent litigation filed by Purdue Pharma earlier this year.
Xtampza ER is claimed to have infringed three Orange Book listed patents that were recently identified to be invalid by the US District Court for the Southern District of New York. They are currently under appeal.
The FDA grants final approval for Xtampza ER once Collegium gets a court order that the listed patents are invalid or not infringed, or if the company settles the Purdue litigation before the expiration of the 30-month period.
Collegium Pharmaceutical chairman and CEO Michael Heffernan said: "The FDA has recognized that Xtampza ER has abuse-deterrent properties consistent with FDA’s final guidance titled, Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.
"We remain confident that Xtampza ER does not infringe the three patents that Purdue has asserted against us. We intend to vigorously defend ourselves against these claims."