EpiCept Corp. (EPCT.PK) said it received further encouraging guidance for the Phase III clinical and nonclinical development and subsequent New Drug Application filing of AmiKet (amitriptyline 4%, ketamine 2%) in the treatment of chemotherapy- induced peripheral neuropathy, or CIPN, based on the issuance of the final minutes of the company's meeting with the U.S. Food and Drug Administration, or FDA, in December 2011.
AmiKet is a prescription topical cream intended for the treatment of peripheral neuropathic pain.
The company stated that in the final meeting minutes recently received by it, FDA acknowledged that painful symptoms due to CIPN represent a significant unmet medical need and encouraged EpiCept to apply for Fast Track designation. In addition, 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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