Xtampza ER Gets Tentative Approval from FDA
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Collegium's Xtampza ER (oxycodone extended-release capsules) 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. With a tentative approval, the FDA has determined that Xtampza ER meets all of the required quality, safety and efficacy standards for approval but it is subject to an automatic stay of up to 30 months as a result of patent litigation.
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. 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 the drug release profile, safety or abuse-deterrent characteristics.
In September, the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted unanimously to support the approval of Xtampza ER.
For more information visit CollegiumPharm.com.