EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) today announced that at a meeting earlier this week with the U.S. Food and Drug Administration (FDA), the Company was granted permission to initiate immediately the Phase III clinical development of AmiKet™. AmiKet™ (4% amitriptyline, 2% ketamine) is a prescription topical cream intended for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) following taxane-based therapy.
Jack Talley, EpiCept President and CEO, commented, "The guidance we received from the FDA during our End of Phase II meeting will permit a quick initiation of AmiKet's remaining clinical development required for a new drug application (NDA). Every year, millions of cancer survivors suffer from the effects of their chemotherapy, and no treatment is yet approved to treat CIPN. AmiKet™ represents a potentially significant benefit to patients suffering from this painful indication, and may address an unmet medical need that is well recognized."
The FDA indicated that a CIPN treatment protocol submitted by the Company will be reviewed expeditiously for a Special Protocol Assessment (SPA).
The Company has submitted its draft meeting minutes for FDA concurrence and upon receipt of the FDA official meeting minutes will provide more details regarding the clinical and non-clinical package required prior to an NDA filing.
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