Collegium Pharmaceutical's ($COLL) hard-to-abuse opioid treatment won unanimous backing from a panel of FDA advisers, clearing the path to a likely approval next month.
The company's drug, Xtampza ER, is an extended-release formulation of oxycodone that Collegium says is crafted to make it harder to abuse. The FDA's committee of independent painkiller experts voted 23-0 in favor of recommending Collegium's treatment for approval, signing off on its potential to manage pain severe enough to merit daily, around-the-clock opioid treatment.
The FDA has promised to hand down a final decision on Xtampza ER by Oct. 12. The agency is not required to follow the votes of its advisers, though it most commonly does.
The panel's vote, which sent Collegium's shares up more than 40% after hours, stood in contrast to the opinions of FDA staff. 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 effect, and patients who take it on an empty stomach are likely to get a dulled effect and thus may choose to updose and put themselves in danger, FDA staff said.
But the agency's analgesics panel didn't see that as a barrier to approval, and the group's unanimous support of Xtampza ER drug came a day after the same group shot down a similar treatment from Purdue Pharma. Dubbed Avridi, Purdue's treatment is also an abuse-deterrent oxycodone formulation, but unlike Xtampza ER, it must be taken on an empty stomach, a requirement the panel said presented too many opportunities for misuse.
Collegium's lead drug uses a proprietary technology the company calls DETERx, making it impervious to crushing and snorting or melting and injecting, according to management. DETERx is key to the company's pipeline, which includes abuse-discouraging takes on oxymorphone, hydrocodone, morphine and methylphenidate.
Headquartered in Canton, MA, Collegium raised $80 million in an IPO in May, going public on the promise of its top prospect.
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