A twice-daily abuse-deterrent oxycodone medication (Xtampza ER, Collegium Pharmaceutical Inc) has received final US Food and Drug Administration (FDA) approval for the management of chronic pain requiring daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
The FDA gave a tentative approval for the New Drug Application in November 2015. The tentative approval followed a unanimous decision of its Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee in September 2015 to support licensing of the product for this indication.
The initial approval was tentative because while the FDA determined that the drug met all required quality, safety, and efficacy standards for approval, patent litigation filed last year by Purdue Pharma LP meant that it was subject to an automatic stay of up to 30 months, the company noted at the time in a statement.
A spokesperson for Collegium confirmed to Medscape Medical News that the litigation has now been disposed, and this represents final approval for the product.
Xtampza ER, Collegium's first product using its proprietary DETERx technology, 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.
In addition to having differentiated, abuse-deterrent properties, Xtampza ER also allows for flexible dosing in patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be dangerous with currently marketed ER products.
During the advisory committee meeting, representatives from Collegium, based in Canton, Massachusetts, showed that the medication could be given by breaking open the capsule and pouring the oxycodone microspheres into a feeding tube or sprinkling them onto soft food or directly into the mouth.
Collegium plans to launch the new product 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.
"Abuse-deterrent opioids are a critical component to fighting the widespread national epidemic of prescription opioid abuse," commented Jeffrey Gudin, MD, director of pain management and palliative care, Englewood Hospital and Medical Center, New Jersey, in the Collegium press release. "The FDA approval of Xtampza ER is incredibly timely as abuse and misuse of opioids is at an all-time high."
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Cite this: FDA Gives Final Approval to Abuse-Deterrent Xtampza ER - Medscape - Apr 29, 2016.
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