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
Los Angeles City officials have filed criminal charges against Soylent CEO Robert Rhinehart for placing a bright red shipping container on Montecito Heights hillside as part of his "experiment in sustainable living." City Attorney Mike Feuer Friday announced that his office has filed multiple criminal... A new study says that if Hillary Clinton is elected then her proposals will strengthen the U.S. economy and create millions of jobs. According to Moody's Analytics, Hillary Clinton's economic proposal would oversee a "somewhat stronger U.S. economy." The conclusion was reached after assessing her... Oil company Exxon Mobil Corp. on Friday reported a 59 percent fall in profit for the second quarter from last year, while Chevron Corp. reported a loss for the quarter, both on lower revenues. The results of both companies were impacted by the low crude oil and natural gas prices as well as weaker refining margins.
comments powered by Disqus
Follow RTT