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FDA Grants ‘Fast Track’ Designation to Extended-Release Morphine and Oxycodone

Abuse-deterrent formulations target moderate-to-severe pain (February 20)

The FDA has granted “fast track” status to both Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, both in development for the treatment of moderate-to-severe pain.

The FDA’s fast track program facilitates the development of medications that are intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs.

The drugs’ developer (Egalet Corporation) plans to submit a new drug application (NDA) for Egalet-001 in late 2014 or early 2015. The NDA submission for Egalet-002 is scheduled for 2016.

According to Egalet, both extended-release medications have been developed in the form of tablets that are specifically designed to deter abuse by physical and chemical manipulation while providing the ability to tailor the release of the active pharmaceutical ingredient.

Source: Egalet Corporation; February 20, 2014.

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