EpiCept Corporation has received further encouraging guidance for the phase III clinical and non-clinical development and subsequent New Drug Application (NDA) filing of AmiKet (amitriptyline 4%, ketamine 2%) in the treatment of chemotherapy- induced peripheral neuropathy (CIPN) based on the issuance of the final minutes of the company's meeting with the US Food and Drug Administration (FDA) in December 2011.
AmiKet is a prescription topical cream intended for the treatment of peripheral neuropathic pain. In the final meeting minutes recently received by EpiCept, the FDA acknowledged that painful symptoms due to CIPN represent a significant unmet medical need and encouraged EpiCept to apply for Fast Track designation. Further, 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 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.
Jack Talley, EpiCept president and CEO, commented, “We are very pleased that the meeting minutes confirmed our belief that the FDA's requirements for the clinical and non-clinical programmes to support an AmiKet NDA filing are achievable. We consider this a very positive outcome that will likely benefit AmiKet's market opportunity and time to NDA filing. Further, we believe this will facilitate SunTrust Robinson Humphrey's efforts to identify potential acquirers or strategic partners to advance AmiKet towards approval and commercialization in the United States. This programme may also facilitate the filing of a marketing authorization application (MAA) for the European Union.”
Earlier this month, EpiCept announced that it had engaged 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 designed to optimize AmiKet's value for the Company's shareholders.
AmiKet is a prescription, topical analgesic cream containing amitriptyline 4% and ketamine 2% designed to provide relief from neuropathic pain, which affects more than 15 million people in the US alone. In the first half of 2011, EpiCept announced positive results from a National Cancer Institute-sponsored study evaluating the efficacy and safety of AmiKet in chemotherapy-induced peripheral neuropathy (CIPN), a painful condition that frequently occurs following systemic chemotherapy and that may interrupt, delay or even prevent completion of potentially curative chemotherapy regimens. A safe and effective therapeutic option for neuropathic pain associated with CIPN would address a significant unmet medical need.
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain.