FDA grants Fast Track designation to EpiCept's AmiKet

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced today that AmiKet™ (amitriptyline 4%, ketamine 2% cream) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). AmiKet™ is the Company's late-stage product for the treatment of neuropathic pain associated with chemotherapy-induced peripheral neuropathy (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. According to the FDA, products with a Fast Track designation oftentimes receive priority review, which may reduce the standard review time by half. The Fast Track designation also allows for more frequent interactions with the FDA during the drug development process.

"We believe the FDA Fast Track designation is confirmation of the pressing need for therapies to treat neuropathic pain associated with CIPN," said Jack Talley, President and Chief Executive Officer of EpiCept. "We expect the receipt of this designation will prove to be highly valuable in our current partnering efforts for AmiKet™."

EpiCept 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.