FDA Approves Abuse-Deterrent Xtampza ER

Collegium announced that the FDA has approved oxycodone (Xtampza ER) extended-release capsules, a twice-daily medication 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 drug uses Collegium’s proprietary DETERx abuse-deterrent technology platform, and is designed to provide adequate pain control while maintaining its drug release profile after being subjected to common methods of ingestion, including chewing and crushing the product before administration. The oxycodone label contains information supporting the administration of the product by sprinkling the capsule contents over soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.

Collegium plans to launch the drug in the United States in mid-2016 with five dosage strengths equivalent to 10, 15, 20, 30 and 40 mg oxycodone hydrochloride.

Oxycodone, an opioid agonist product, is not indicated as an as-needed analgesic.

The most common adverse events (>5%) reported by patients in the Phase III clinical trial during the titration phase were nausea (16.6%), headache (13.9%), constipation (13.0%), somnolence (8.8%), pruritus (7.4%), vomiting (6.4%) and dizziness (5.7%).