Collegium's pain drug wins a 'tentative' FDA approval with Purdue blocking the way

Collegium Pharmaceutical ($COLL) won FDA approval for its abuse-deterrent take on oxycodone, but an ongoing patent dispute with Purdue Pharma stands in the way of the drug's launch.

Missing its promised approval deadline by about three weeks, the FDA finally signed off on Collegium's Xtampza ER, an extended-release formulation of oxycodone that the company says is impervious to crushing and snorting or melting and injecting. The drug is cleared as a treatment for chronic pain severe enough to require daily, 24-hour opioid treatment.

But, because of a patent infringement suit brought on by Purdue in March, Collegium will have to wait up to 30 months before it can market Xtampza ER. Purdue claims Collegium's drug infringes three of its patents related to extended-release oxycodone. A federal court ruled those patents invalid earlier this year, but Purdue has appealed that decision, triggering an automatic FDA delay until Collegium can secure a court order clearing its drug.

"We remain confident that Xtampza ER does not infringe the three patents that Purdue has asserted against us," Collegium CEO Michael Heffernan said in a statement. "We intend to vigorously defend ourselves against these claims."

A panel of independent FDA advisers voted unanimously in favor of approving Xtampza ER at a September meeting, but the drug got a less favorable review for agency staff beforehand. In a briefing released ahead of the committee meeting, agency reviewers expressed concerns with Xtampza ER's label. The drug must be taken with food for maximum efficacy, and thus patients who take it on an empty stomach are likely to get a dulled effect and may choose to updose and put themselves in danger, FDA staff said. The same panel voted 23-1 against an immediate-release oxycodone from Purdue in September, concerned about its need to be taken without food.

Xtampza ER is the most advanced candidate in Collegium's pipeline of abuse-blocking analgesics, which includes formulations of oxymorphone, hydrocodone, morphine and methylphenidate. The company, headquartered in Canton, MA, raised $80 million in an IPO in May.

- read the statement