EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today announced that it has filed for Fast Track designation for AmiKet™ (amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced peripheral neuropathy (CIPN) with the U.S. Food and Drug Administration (FDA). AmiKet™ is a prescription topical cream under late stage clinical development by EpiCept for the treatment of peripheral neuropathic pain.
Jack Talley, EpiCept President and CEO, commented, "Fast Track designation would significantly accelerate the regulatory development of AmiKet™, and given the encouragement we received from the FDA and their recognition that the pain associated with CIPN represents a significant unmet medical need, we are optimistic that this designation will be granted. In addition, a Fast Track designation is likely to bolster our ongoing efforts to identify strategic partners to conduct pivotal clinical and regulatory work necessary for eventual approval and commercialization in the U.S. and the EU," Mr. Talley concluded.
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.
On January 23, 2012, EpiCept announced receipt of finalized guidance from the FDA for the Phase III clinical and nonclinical development and subsequent New Drug Application (NDA) filing of AmiKet™. As part of this guidance the FDA waived several expensive and time-consuming non-clinical toxicology studies, and indicated that a single, four-arm factorial trial might suffice for regulatory approval if combined with other pivotal data in another neuropathy such as diabetic peripheral neuropathy. The key element of the proposed Phase III clinical program is a 12-week, four-arm, factorial-designed trial in CIPN that would seek to demonstrate AmiKet's superiority compared with placebo and with each of the component drugs of AmiKet™, amitriptyline and ketamine.
EpiCept intends to submit the protocol for this trial to the FDA via a Special Protocol Assessment (SPA). An additional two-arm efficacy study in another painful peripheral neuropathy may be performed as an alternative strategy to a second factorial-designed trial for the NDA filing, which could potentially lead to a broader label for AmiKet™ in the treatment of peripheral neuropathic pain. In addition to the positive outcome previously reported for AmiKet™ in CIPN, EpiCept has reported statistically significant positive results in the treatment of pain from post-herpetic neuralgia in several Phase II studies, the non-inferiority of AmiKet™ compared with gabapentin in another placebo-controlled study, and a positive trend in the treatment of pain in a diabetic neuropathy Phase II study.
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 shareholders.