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

Editors Pick
H&R Block, Inc., the largest U.S. tax preparer, said Wednesday after the markets closed that its third quarter loss narrowed sharply from last year, as revenue surged due to an earlier opening of the Internal Revenue Service's e-file system this tax season. The company's quarterly loss per share also smaller than analysts estimated, but its quarterly revenue fell short of analysts' forecast. Microsoft co-founder Paul Allen's maritime plunge took an exciting yet somber turn, after he found the wreck of a once-feared World War II Japanese battleship that met its doom by enemy torpedoes decades ago near the Philippines. A new study reveals that more large companies in the U.S. are run by men with the names John, Robert, William or James than the total number of women CEOs. For each women CEO of S&P 1500 companies there are four men CEOs named John, Robert, William or James, according to a study conducted by the New...
comments powered by Disqus
Follow RTT