Xtampza ER is an oral extended-release formulation of the opioid oxycodone. It was approved by the US Food and Drug Administration (FDA) for the management of severe pain on April 26.
In Xtampza capsules active pharmaceutical ingredients (API) particles are enclosed in waxy, fatty-acid microspheres. These microspheres do not release the drug actives when subjected to physical and chemical manipulation.
The approach has advantages over antagonist and irritant-based anti-abuse technologies according to Collegium which said because the microspheres maintain the desired release profile products can be delivered as sprinkles directly or via feeding tubes.
Legal battle
Xtampza contains the same active ingredient as Purdue Pharma’s $3bn a year pain management medication, OxyContin OP.
The launch comes four months after the U.S. Court of Appeals for the Federal Circuit upheld an earlier ruling that invalidated four OxyContin OP patents owned by Purdue.
Collegium said Xtampza will be supported by 120-strong sales force that will market it to pain specialists and specialty representatives who will target hospitals and long-term care facilities.
Other candidate Collegium drugs being developed using the Deterx technology include versions of oxymorphone, hydrocodone, morphine and methylphenidate.