Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.EpiCept has received permission from the US FDA to commence the Phase III clinical development of AmiKet.
Subscribe to our email newsletter
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.