AmiKet regulatory update

EpiCept said EMA's CHMP issued formal scientific advice on the development of AmiKet to treat chemotherapy-induced peripheral neuropathic pain (CIPN). CHMP recommended EpiCept include in an MAA a single, 12-week, 4-arm, factorial-designed trial in CIPN to compare AmiKet to placebo and to each of AmiKet's components, amitriptyline and ketamine. The agency will also require a 2-arm efficacy study in CIPN or another neuropathy as well as non-clinical requirements, including a 90-day dermal toxicity study in a non-rodent species, a dermal phototoxicity study in a rodent and an ocular toxicity study. The company said the requirements are consistent with FDA guidance and it will design a Phase III program to meet submission requirements in the EU and U.S., where the product has Fast Track designation. ...