AmiKet (4% amitriptyline, 2% ketamine) is a prescription topical cream intended to treat chemotherapy-induced peripheral neuropathy (CIPN) following taxane-based therapy.
EpiCept announced positive results from a study that assessed the efficacy and safety of AmiKet in chemotherapy-induced peripheral neuropathy (CIPN).
EpiCept president and CEO Jack Talley said the FDA has permitted a quick initiation of AmiKet’s remaining clinical development required for a new drug application (NDA).
"AmiKet represents a potentially significant benefit to patients suffering from this painful indication, and may address an unmet medical need that is well recognized," Talley added.