EpiCept Corp. (EPCT.PK) on Tuesday said its late-stage topical analgesic cream AmiKet has been granted fast track designation by the U.S. Food and Drug Administration.
The product is to treat neuropathic pain associated with chemotherapy-induced peripheral neuropathy, or CIPN, in patients previously treated with taxane-based chemotherapy.
The FDA's fast track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs.
Products with such a designation often receive priority review, which may reduce the standard review time by half. The designation also allows for more frequent interactions with the FDA during the drug development process.
Jack Talley, President and Chief Executive Officer of EpiCept, said, "We believe the FDA Fast Track designation is confirmation of the pressing need for therapies to treat neuropathic pain associated with CIPN."
EpiCept had previously announced the engagement of SunTrust Robinson Humphrey to assist in exploring strategic alternatives to maximize the commercial opportunity of AmiKet. The engagement will focus on the identification and implementation of a strategy to optimize AmiKet's value for the company's stockholders.
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by RTT Staff Writer
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