logo
Share SHARE
FONT-SIZE Plus   Neg

EpiCept's AmiKet Receives FDA's Fast Track Designation

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Airline industry profits in 2016 are now expected to be slightly lower than previous view, yet would reach a peak of $35.6 billion, the International Air Transport Association or IATA said Thursday. Meanwhile, profits would decline in 2017 amid overcapacity, rising fuel costs and political turmoil. Burger King has introduced a donut burger in Israel to celebrate the Jewish festival of Hanukkah. The burger will be called the SufganiKing, a play on the Hebrew word for donut, which is sufganiyot. The burger will be sold for about $4. Ciena Corp., a provider of communications networking solutions, on Thursday reported a turnaround to profit in the fourth quarter on higher revenues and lower expenses. However results for the quarter missed analysts' estimates. Looking ahead, the company forecast revenue for the first quarter of fiscal 2017 in line with analysts' expectations.
comments powered by Disqus
Follow RTT