Published on April 10, 2012 at 1:11 AM
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.
Source: AmiKet