Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone 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.
Xtampza ER is Collegium’s first product utilizing its proprietary DETERx® technology platform, and 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 prior to administration. The Xtampza ER label contains information supporting the 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.
Collegium plans to launch Xtampza ER in the United States in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone hydrochloride.
