FDA to Review 2 Abuse-Deterrent Opioids

The FDA recently accepted for review New Drug Applications (NDAs) for Collegium Pharmaceuticals’ extended-release oxycodone formulation (Xtampza ER) and Pfizer’s extended-release oxycodone hydrochloride and naltrexone hydrochloride (ALO-02), a pair of opioid analgesics with abuse-deterrent properties.

Collegium’s NDA, which seeks FDA approval for Xtampza ER to treat chronic pain, was supported by data from a phase 3, placebo-controlled clinical trial that evaluated the drug’s safety, tolerability, and efficacy in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back pain.

Xtampza ER was designed with Collegium’s DETERx technology platform, which prevents abuse via oral administration, injection, nasal insufflation, or inhalation while maintaining the drug’s extended-release properties after attempted manipulation, according to a manufacturer press release. The abuse-deterrent characteristics of Xtampza ER was tested in a head-to-head study comparing Xtampza ER with OxyContin, data from which was also included in Collegium’s NDA.

“Collegium is committed to developing and commercializing a portfolio of products that address the epidemic of chronic pain and the growing problems associated with non-medical use, abuse, and misuse of prescription products by leveraging our proprietary DETERx technology platform,” Collegium CEO Michael Heffernan stated. “Upon approval, Xtampza ER has the potential to provide a novel treatment option to patients in need of chronic pain therapy.”

Pfizer’s NDA seeks FDA approval for ALO-02 to manage pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is supported by data from 2 phase 3 trials in patients with moderate-to-severe, chronic, noncancer pain. ALO-02 was also designed to prevent abuse when taken by oral, intranasal, or intravenous routes, a property that Pfizer evaluated in 3 abuse-potential studies.

Last week, the FDA accepted another NDA for an investigational abuse-deterrent narcotic, Inspirion Delivery Technologies’ MorphaBond ER. The agency previously approved 2 additional opioids with abuse-deterrent technology: Purdue Pharma’s Hysingla ER, which was launched in the United States in January 2015, and a new formulation of Zogenix’s Zohydro ER.