FDA to Review Valbenazine for Tardive Dyskinesia
Neurocrine Biosciences announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for valbenazine for the treatment of tardive dyskinesia, a rarely reversible condition with currently no FDA-approved treatments.
The NDA submission was based on drug manufacturing data, results from extensive preclinical testing, and clinical trials including the Kinect 2 and Kinect 3 studies which evaluated once daily dosing of valbenazine in over 330 patients with tardive dyskinesia. Neurocrine expects to receive notification from the FDA regarding acceptance and timeframe for the NDA review process in October 2016.
Valbenazine previously received Breakthrough Therapy designation from the FDA for the treatment of tardive dyskinesia. It is also currently being investigated in ongoing Phase 2 studies for the treatment of Tourette syndrome.
Valbenazine (NBI-98854) is a novel, highly-selective vesicular monoamine transporter 2 (VMAT2) inhibitor.
For more information call (858) 617-7989 or visit Neurocrine.com.