CHMP provides advice for AmiKet (EpiCept Inc) MAA in treatment of Peripheral Neuropathy

The CHMP has provided scientific advice for development and subsequent Marketing Authorization Approval (MAA) filing of AmiKet (amitriptyline 4%, ketamine 2%), from EpiCept Inc., for the treatment of chemotherapy-induced Peripheral Neuropathy (CIPN). It recommended that the proposed clinical program consist of a single 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. An additional two-arm efficacy study in CIPN or another neuropathy is required to complete the clinical requirements of the application. The advice provided a summary of the additional nonclinical program requirements to file an MAA, which included a 90-day dermal toxicity study in a non-rodent species, a dermal phototoxicity study in a rodent and an ocular toxicity study.