US regulators have agreed to review Teva’s application to market its abuse-resistant painkiller CEP-33237.

The New Drug Application is seeking clearance 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.

CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release hydrocodone that incorporates Teva’s abuse-deterrence technology.

According to the firm, Phase III trials have shown that CEP-33237 significantly improved treatment of patients’ chronic low back pain, and a safety profile consistent hydrocodone and other opioid analgesic therapies.