Xtampza ER, Collegium’s lead product candidate, is an abuse-deterrent, extended-release, oral formulation of oxycodone. Xtampza ER is being developed 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.
The Company’s NDA submission for Xtampza ER was accepted for review by the FDA on February 10, 2015. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 12, 2015 for completion of its review of the Xtampza ER NDA.
"The upcoming FDA advisory committee meeting represents progress toward our goal of obtaining approval of Xtampza ER. We look forward to discussing the efficacy, safety and abuse-deterrent data included in our NDA with the Advisory Committee and will continue to work with the FDA through the review period," stated Michael Heffernan, CEO of Collegium.
Collegium’s lead product candidate, Xtampza ER, is an abuse-deterrent, extended-release, oral formulation of oxycodone, in development 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.
Collegium developed Xtampza using its proprietary DETERx technology platform to address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.
In addition, Collegium’s preclinical studies and clinical trials have shown that the contents of the Xtampza capsule can be removed from the capsule and sprinkled on food, directly into the mouth or administered through feeding tubes, without compromising their drug release profile, safety or abuse-deterrent characteristics.
By contrast, OxyContin OP, which is formulated in hard tablets, has a black box warning label stating that crushing, dissolving or chewing can cause rapid release and absorption of a potentially fatal dose of the active ingredient. Approximately 11 million patients in the United States suffer from chronic pain and have difficulty swallowing.