SURESNES, France--(BUSINESS WIRE)--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.
About ATX01
ATX01 is a novel and patented topical formulation of amitriptyline. Its non-systemic mode of action locally inhibits pain signaling by the skin’s nerve fibers whilst minimizing systemic penetration, thus avoiding unwanted toxicity. Phase 1 clinical development showed favorable local and systemic tolerance in healthy volunteers and low systemic passage. The planned Phase 2 development will establish clinical efficacy in patients with chemotherapy-induced peripheral neuropathy.
About AlgoTx
AlgoTx is a European biotech founded in 2018 to develop innovative solutions for complex pain, with initial programs focusing on chemotherapy-induced neuropathic pain and erythromelalgia (US and EU ODD granted).
