|Collegium CEO Michael Heffernan|
Collegium Pharmaceutical ($COLL) watched the FDA-promised approval date come and go for its abuse-deterrent painkiller, putting an indefinite hold on the company's plans to launch its first product.
The company's opioid treatment, Xtampza ER, won unanimous backing from a panel of agency advisers last month, and the FDA committed to handing down a final decision on the drug by Monday. But the agency has since advised Collegium that it "will not be able to complete its review" on time, the company said, and management provided no other details. The FDA doesn't comment on drugs under review.
"We are confident in the Xtampza ER program and our NDA submission," Collegium CEO Michael Heffernan said in a statement. "We continue to work closely with the FDA as they complete their review."
Collegium's shares fell as much as 9% overnight on investor worries that there could be an issue with the drug's filing that could significantly delay or even prevent approval.
Before its success at the FDA panel in September, Xtampza ER got a less enthusiastic review from 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 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.
Xtampza ER is an extended-release formulation of oxycodone that Collegium says is crafted to make it harder to abuse. The 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.
- read the statement