Little Rock, AR – InterveXion Therapeutics, a clinical stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IXT-m200, also known as ch-mAb7F9, an investigational drug candidate for the treatment of patients with methamphetamine addiction.
The FDA Fast Track process is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions so that an approved product can reach the market expeditiously. Fast Track designation provides for frequent consultation between the FDA and the sponsor, as also offers the potential for “rolling review” of completed sections of the New Drug Application (NDA), and potential eligibility for accelerated approval and priority review.
IXT-m200 is designed on the principle of pharmacokinetic antagonism, and offers a highly novel approach to modulating drug addiction. Rather than blocking methamphetamine’s effects in the brain, IXT-m200 sequesters methamphetamine into the blood and away from the brain, potentially reducing the powerful reinforcing behavioral effects of methamphetamine. InterveXion has conducted a robust nonclinical evaluation of the pharmacology, toxicology, and pharmacodynamics of IXT-m200, and has completed an initial Phase 1 clinical safety study with this investigational product.
“We are very pleased with the Fast Track designation by the FDA for IXT-m200″, said Brooks Gentry, M.D., Chief Medical Officer of InterveXion. “Methamphetamine addiction has a devastating impact on the lives of patients, their families, and their communities, and InterveXion is devoted to developing novel therapies to address these critical unmet needs. Fast Track designation will help further facilitate development of IXT-m200, and we look forward to continued partnership with the FDA in development of this agent”.