Abuse-Deterrent Painkiller Xtampza ER Wins Full FDA Approval

Product overcomes patent-infringement lawsuit

Xtampza ER (oxycodone) extended-release (ER) capsules CII (Collegium Pharmaceutical, Inc.) has won full marketing approval from the FDA. The drug was awarded tentative approval in November 2015, but full approval was contingent on the outcome of a lawsuit filed by Purdue Pharma against Collegium.

Purdue, which has developed abuse-deterrent versions of OxyContin (oxycodone), claimed that Xtampza infringed some of its patents. In February, however, the District Court of Massachusetts ruled in favor of Collegium.

Xtampza ER is an opioid agonist product indicated 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. It is designed to provide adequate pain control while maintaining its drug-release profile after being subjected to common methods of manipulation, including chewing and crushing the product before administration.

Xtampza ER is meant to be taken after a meal for maximum effect. The label contains information supporting administration of the product by sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER opioid formulations, Xtampza ER should be reserved for use in patients for whom alternative treatment options, such as nonopioid analgesics or immediate-release opioids, are ineffective, are not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Xtampza ER is not indicated as an as-needed analgesic.

Sources: Collegium Pharmaceutical; April 26, 2016; and Reuters; April 26, 2016.