EpiCept has received fast track designation for AmiKet (amitriptyline 4%, ketamine 2% cream) from the US Food and Drug Administration (FDA).
AmiKet is indicated for the treatment of neuropathic pain associated with chemotherapy-induced peripheral neuropathy in patients previously treated with taxane-based chemotherapy.
According to the FDA, products with a fast track designation oftentimes receive priority review, which may reduce the standard review time by half.
EpiCept president and chief executive officer Jack Talley said: "We expect the receipt of this designation will prove to be highly valuable in our current partnering efforts for AmiKet".
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/epicept-receives-fda-fast-track-designation-for-amiket-100412
