Today, Aimed Alliance presented testimony before a joint meeting of the U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The joint committees discussed a new drug application for an extended-release oxycodone product that incorporated abuse-deterrent properties to help prevent abuse of the controlled substance.
Aimed Alliance, represented by Director of Public Policy, Stacey L. Worthy, called for a recommendation of approval of the new drug application because it is designed to be less susceptible to common forms of abuse, safer for patients who unintentionally misuse opioids, and satisfies a currently unmet medical need in providing access to an effective treatment for patients who experience difficulty swallowing. In response to the FDA’s concern about the medication’s food effect, Worthy urged the panel to incorporate an educational component into the shared Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids given that many opioids within the class have similar food effects.
If approved, the medication would provide patients for whom it is medically necessary with a novel and innovative treatment option.
Aimed Alliance is pleased that the advisory committee voted 23-0 in favor of recommending FDA approval of the new drug application. You can read more via Tech Times.
Last Updated on May 7, 2020 by Aimed Alliance
