Breaking news: FDA issues CRL for Remoxy, cites inconsistencies in its drug release performance

Pfizer’s second attempt at an abuse-resistant formulation of oxycodone (Remoxy) recently received a complete response letter (CRL) from FDA. Just a week earlier, FDA approved another of the drug maker’s abuse-resistant products - immediate-release Oxecta (oxycodone HCl) - for the management of acute and chronic moderate-to-severe pain.

"Given the inherent safety concerns with a potent narcotic agent like oxycodone, a complete response letter driven by questions of inconsistency in drug release performance would be considered of clear clinical justification, given FDA's foremost duty to protect the safety and wellbeing of potential end-users of such a product," said David Calabrese, RPh, MHP, clinical editor of Drug Topics' sister publication Formulary and chief clinical officer, Med Metrics Health Partners, Worcester, Mass.

Pfizer is working to evaluate the issues described in the CRL about Remoxy Extended-Release Capsules CII and plans to discuss them further with FDA, according to a company release. The CRL reportedly raised concerns related to the chemistry, manufacturing, and controls section of the NDA for Remoxy.

Remoxy is an investigational extended-release oral formulation of oxycodone for the relief of moderate-to-severe pain requiring continuous, around-the-clock opioid treatment. It was developed by Pain Therapeutics using Durect Corporation’s Oradur technology, which is designed to discourage common methods of tampering.

On June 20, 2011, FDA approved Pfizer’s and Acura Pharmaceuticals’ Oxecta Tablets CII for the management of acute and chronic moderate-to-severe pain when the use of an opioid analgesic is appropriate. Oxecta is the first immediate-release oxycodone HCl formulation that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse. This aversion technology is composed of commonly used pharmaceutical ingredients. Pfizer is licensing the technology in Oxecta from Acura.