Topical Amitriptyline fast tracked for Chemotherapy-Induced-Neuropathic-Pain

The Food and Drug Administration (FDA) has awarded Fast Track designation to Topical Amitriptyline for the treatment of chemotherapy-induced neuropathic pain.

AlgoTx announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA), for the development of ATX01 in chemotherapy-induced neuropathic pain.

"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."

Chemotherapy-induced neuropathic pain is a debilitating condition caused by neurotoxic cancer agents such as platinum derivatives, taxanes, epothilones, plant alkaloids and other drugs. The severe pain and associated adverse impact on quality of life frequently result in the reduction or interruption of cancer treatment.

Fast Track is a process designed to facilitate the development and expedite the review of treatments for serious conditions, which potentially address unmet medical needs. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.

ATX01 recently obtained an IND for its Phase 2 trial in CIPN due to start in late 2022, and an Orphan Drug Designation for development in erythromelalgia.