FDA Approves sNDA for Abuse Deterrent, Extended-Release Oxycodone

The US Food and Drug Administration has approved a supplemental new drug application (sNDA) for an abuse-deterrent, extended-release oxycodone formula (Xtampza, Collegium Pharmaceutical) for the management of severe pain that requires daily, long-term opioid treatment.

The approval resulted in 3 main changes to the label. Pharmacokinetic, comparative data for the extended-release drug will be added, showing a comparison with the abuse-deterrent version of oxycodone hydrochloride extended-release tablets (OxyCotin) and a control of oxycodone immediate release. It also adds results from a study examining the association between the extended-release and a lower mean in Drug Liking and Take Drug Again Visual Analogue Scale scores, as well as an oral abuse-deterrent claim.

“The data added to the Xtampza ER label has important implications for clinicians and patients when considering safety as well as abuse, misuse, and diversion,” said Jeff Gudin, MD, the director of Pain Management and Palliative Care at the Englewood Hospital and Medical Center in New Jersey, said in a statement. This approval comes on the heels of an announcement from FDA Commissioner Scott Gottlieb about possible strategies being explored by the agency to deter abuse and misuse of opioid medications.

In the study, the mean Drug Liking scores were statistically lower with the extended-release formula, both intact (68.8) and chewed (73.4), compared with oxycodone immediate release (81.8), and Take Drug Again Visual Analogue Scale scores were also lower, at 70.2 and 73.7 for intact and chewed extended release Xtampza, respectively, compared to 75.4 with crushed immediate-release oxycodone.

The extended-release formula is the first from Collegium that utilizes DETERx technology. The drug will be reserved for sole use by patients that otherwise do not have adequate alternatives to opioids to provide the necessary pain management.

The most common adverse events (AEs) experienced by patients in clinical trials were nausea (16.6%), headache (13.9%), constipation (13%), somnolence (8.8%), pruritus (7.4%), vomiting (6.4%), and dizziness (5.7%).

“The FDA approval of the sNDA is a major milestone for Collegium. With the addition of comparative pharmacokinetic data with OxyContin and an oral abuse-deterrent claim, Xtampza ER is the only single agent oxycodone with oral, intranasal and intravenous abuse-deterrent labeling,” Michael Heffernan, the CEO of Collegium, said in a statement. “Collegium is committed to supporting responsible, appropriate opioid prescribing for only those patients suffering from chronic pain who don’t have alternative non-opioid treatment options.”

In a similar breadth, earlier this month, Braeburn Pharmaceuticals announced the FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted to jointly recommend the approval of CAM2030, a therapy for adults with opioid use disorder (OUD).

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