EpiCept Corporation Receives Scientific Advice from European Medicines Evaluation Agency for AmiKet™ CIPN Program
Published: Jun 04, 2012
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News: EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today announced that it has received formal scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the clinical and nonclinical development and subsequent Marketing Authorization Approval (MAA) filing of AmiKet™ (amitriptyline 4%, ketamine 2%) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). AmiKet™ is a topical cream intended for the treatment of peripheral neuropathic pain. In general the CHMP’s requirements are closely aligned with the recent guidance given EpiCept by the U.S. Food and Drug Administration (FDA).