FDA Assesses Teva's Abuse-Deterrent Hydrocodone

Teva Pharmaceutical Industries recently announced that the FDA has accepted for review a New Drug Application (NDA) for its investigational formulation of extended-release hydrocodone bitartrate with abuse-deterrent properties.

The NDA seeks the FDA’s approval of CEP-33237 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate.

Teva supported its submission with data from a phase 3 study that evaluated the drug’s efficacy, safety, and abuse potential. The research team found that trial participants treated with CEP-33237 experienced significant improvements in chronic lower back pain. The researchers also determined that the drug’s abuse potential was significantly lower than that of immediate-release hydrocodone in nondependent, recreational opioid users.

“Teva is committed to developing innovative approaches to helping advance responsible pain management and is pleased the FDA is moving forward in its consideration of CEP-33237,” said Michael Hayden, MD, PhD, president of global R&D and chief scientific officer at Teva, in a press release. “With positive results from Human Abuse Liability studies in the 2 most common routes of hydrocodone abuse, CEP-33237 with potential abuse deterrence properties, represents a positive step towards responsible pain management.”

CEP-33237’s safety profile was deemed consistent with that of hydrocodone and other opioid analgesic therapies. The most common adverse events experienced by hydrocodone-treated trial participants included nausea, constipation, vomiting, headache, somnolence, and dizziness.

“The impact of living with chronic pain can be devastating, affecting many aspects of daily life,” said Richard Malamut, MD, vice president of global clinical development at Teva. “If approved, CEP-33237 will provide an important treatment option for people living with chronic pain and health care professionals who care for them.”

The FDA is currently reviewing a number of other opioids with abuse-deterrent properties, including Inspirion Delivery Technologies’ MorphaBond ER, Collegium Pharmaceuticals’ Xtampza ER, and Pfizer’s ALO-02. The agency previously approved 2 additional abuse-deterrent narcotics: Purdue Pharma’s Hysingla ER, which was launched in the United States in January 2015, and a new formulation of Zogenix’s Zohydro ER.