Pain Therapeutics has announced the resubmission to the US Food and Drug Administration (US FDA) of a New Drug Application (NDA) for REMOXY ER, its lead drug candidate. The Company expects a six-month review cycle by US FDA.
“This NDA resubmission is a milestone that brings us closer to offering a new and different abuse-deterrent treatment option for people with chronic pain,” said Remi Barbier, president & chief executive officer.
Pain Therapeutics developed REMOXY ER as an abuse-deterrent, extended-release, capsule formulation of oxycodone, a prescription drug for severe pain. REMOXY ER is designed to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients with pain. REMOXY ER has a thick, sticky, high-viscosity capsule formulation designed to deter unapproved routes of drug administration, such as injection, snorting or smoking.
The REMOXY NDA was filed through the 505(b)(2) regulatory pathway. Pain Therapeutics expects to be notified by FDA of a Prescription Drug User Fee Act (PDUFA) date within 60 days.
The development program for REMOXY ER was designed to meet regulatory standards of clinical and non-clinical safety, efficacy and abuse-deterrence, including positive results of a recently completed nasal abuse potential study.