Collegium Pharmaceutical, Inc. announced the commercial launch of Xtampza ER (oxycodone) extended-release (ER) capsules in the United States. Xtampza ER was approved by the US Food and Drug Administration (FDA) 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 extended-release drug release profile after being subjected to common methods of abuse and accidental misuse. While abuse of Xtampza ER is still possible, FDA has determined that the product has abuse-deterrent properties. The Xtampza ER label supports alternate administration options, including, 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.
“The launch of Xtampza ER is a culmination of many important milestones for Collegium that span the last several years,” said Michael Heffernan, CEO of Collegium. “We are committed to supporting responsible, appropriate prescribing for patients suffering from chronic pain who don’t have alternative non-opioid treatment options. Xtampza ER will provide clinicians with another treatment option for these patients.”
The Xtampza ER commercial launch will be supported by a field sales force of approximately 120 retail sales professionals with a primary focus on pain specialists. In addition, an institutional focused sales force of specialty sales representatives will target hospitals and long term care facilities.
“We are prepared and incredibly excited to launch Xtampza ER. Key stakeholders, including healthcare providers and payers, have responded favorably to the differentiated attributes of the Xtampza ER label,” said Barry Duke, chief commercial officer. “Our team has built an integrated commercial model to leverage the unique attributes of Xtampza ER across the retail, out-patient setting, institutional channel and long term care channel.”
