The Food and Drug Administration (FDA) has granted Fast Track designation to ATX01 for the treatment of chemotherapy-induced neuropathic pain.
ATX01 is a topical formulation of amitriptyline designed to directly inhibit pain signaling in the nerve fibers on the epidermis and dermis, while minimizing systemic absorption. In a phase 1 trial, favorable local and systemic tolerance with low systemic penetration was observed in healthy participants administered ATX01.
“The FDA’s Fast Track designation of ATX01 reflects the critical unmet medical need of 60% of chemotherapy patients suffering from chemotherapy-induced neuropathic pain,” said Stéphane Thiroloix, founder and CEO of AlgoTx, “We look forward to interacting closely with the FDA to bring relief to patients as quickly as possible.”
The Company plans to initiate a phase 2 trial evaluating ATX01 for the treatment of chemotherapy-induced neuropathy pain in late 2022.
AlgoTx’s ATX01 granted Fast Track designation by FDA for chemotherapy-induced neuropathic pain. News release. AlgoTx. Accessed June 9, 2022. https://www.businesswire.com/news/home/20220608006199/en/AlgoTx%E2%80%99s-ATX01-Granted-Fast-Track-Designation-by-FDA-for-Chemotherapy-Induced-Neuropathic-Pain
Source: Medical Bag https://www.medicalbag.com/home/news/topical-amitriptyline-gets-fast-track-status-for-chemotherapy-induced-neuropathic-pain/