Collegium announced that the Food and Drug Administration (FDA) has approved Xtampza ER (oxycodone) extended-release (ER) 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.
Xtampza ER utilizes the proprietary DETERx technology platform that provides pain management while maintaining its extended-release drug profile even after common methods of tampering, including chewing and crushing prior to administration. Xtampza ER may be administered by sprinkling the contents of the capsule on soft foods or into a cup for ingestion, or through a gastrostomy or nasogastric feeding tube.
In September 2015, 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. It was then granted tentative approval from the FDA in November 2015 after it was determined that the product met all of the required quality, safety, and efficacy standards for approval. However, it was subject to an automatic stay of up to 30 days due to a patent litigation.
Xtampza ER will be available as five dosage strength capsule equivalent to 10mg, 15mg, 20mg, 30mg, and 40mg oxycodone HCl. It is anticipated to launch in the middle of 2016.
For more information call (855) 331-5615 or visit CollegiumPharma.com.