EpiCept Corporation (EPCT) Receives Finalized FDA Guidance for AmiKet™ Phase III CIPN Program and Regulatory Strategy
1/23/2012 6:12:12 AM
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regulatory News:
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today announced that it received further encouraging guidance for the Phase III clinical and nonclinical 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 U.S. 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.
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