The FDA grants Fast Track Designation to ODG’s investigation of oxfendazole for the treatment of trichuriasis
The Oxfendazole Development Group has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the investigation of oxfendazole for the treatment of trichuriasis. This designation is made in recognition of the seriousness of infection with the parasitic worm Trichuris trichiura,1 as well as the unmet medical need arising from the poor efficacy of currently approved treatments for this parasite.2
Presently approved as a deworming medicine in animals, oxfendazole is being investigated as an improved deworming medicine for some human parasitic worms. Fast Track Designation conveys several benefits to our development program including more frequent meetings with the FDA, more frequent written communication from the FDA, and eligibility for Rolling Review, Accelerated Approval and Priority Review, if relevant criteria are met.
The Oxfendazole Development Group is pleased to have received this opportunity to work more closely with the FDA to accelerate oxfendazole’s development for human use.
- Stephenson L, Holland C, Cooper EJP. The public health significance of Trichuris trichiura. 2000;121(S1):S73-S95.
- Keiser J, Utzinger J. Efficacy of current drugs against soil-transmitted helminth infections: systematic review and meta-analysis. JAMA. 2008;299(16):1937-1948.
Human Phase I study: the results of the Phase I Single Ascending Dose (SAD) study of oxfendazole are now published. See the safety profile and pharmacokinetics of oxfendazole in healthy volunteers: publication Phase I SAD study
Preclinical review: Our review of the evidence of oxfendazole’s safety and efficacy against both gut and tissue dwelling parasitic worms in animals, as well as more recent safety and pharmacokinetic data, supporting oxfendazole’s investigation for use as an anthelmintic in humans. Read our review: oxfendazole expert review