FDA Denies Remoxy Approval
On Aug. 6, Pain Therapeutics Inc. received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application for Remoxy extended-release (ER).1 Remoxy ER is an investigational abuse-deterrent oxycodone formulation designed to manage pain severe enough to require daily, long-term opioid treatment when alternative treatment options are inadequate.
In reviewing the application, the FDA concluded the data submitted do not support the premise that the product’s benefits outweigh its risks. On June 26, a joint meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14–3 against approving Remoxy ER.2 In September 2016, the first complete response letter for Remoxy ER was submitted, and the treatment was not approved because it did not mention clinical safety, drug efficacy, manufacturing, stability or bioequivalence data, aside from other required information.3
Remoxy ER is a gel capsule with twice-daily releasing properties. It has a thick, sticky, high viscosity, hydrophobic gel that cannot be cut, grated or divided into smaller particles. The gel formulation resists attempts to put it into a syringe and inject it. The clinical efficacy was studied in more than 2,400 individuals.