The U.S. Food and Drug Administration (FDA) has granted a France-based brand, AlgoTx, with a Fast Track designation to further advance the development of chemotherapy-induced neuropathic pain treatment, according to a press release.
“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,” Founder and CEO of AlgoTx Stéphane Thiroloix said in the release. “We look forward to interacting closely with the FDA to bring relief to patients as quickly as possible.”
Fast Track is designed to accelerate the review of treatments for serious conditions to fulfill 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,” according to the press release.
Chemotherapy-induced neuropathic pain is considered severe enough to be included. The condition derives from AlgoTx neurotoxic cancer agents such as platinum derivatives, taxanes, epothilones and plant alkaloids, among others.
“The severe pain and associated adverse impact on quality of life frequently result in the reduction or interruption of cancer treatment,” the press release stated.
ATX01 also recently obtained an IND for the second phase of its trial in CIPN, set to start later on this year, as well as an Orphan Drug Designation for development in erythromelalgia.