Egalet Corp. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status for 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.
FDA’s Fast Track program facilitates the development of drugs intended to treat serious or life‑threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval.
“Fast Track designation for Egalet-001 and Egalet-002 is an important step forward in the development of our two lead product candidates,” said Bob Radie, Egalet’s president and chief executive officer. “We look forward to working with the FDA and plan to submit the new drug application for Egalet-001 in the fourth quarter of this year.”
With Fast Track status, sponsors can have more frequent and timely communications and meetings with the FDA regarding product development plans. The Fast Track designation may result in eligibility for priority review of New Drug Applications.
Date: February 20, 2014
Source: Egalet Corp.