FDA accepts NDA for SD 809 (deutetrabenazine) as a proposed treatment for tardive dyskinesia ,- Teva Pharmaceuticals
Teva Pharmaceutical Industries Ltd. announced the FDA has accepted the New Drug Application (NDA) and granted Priority Review for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2017.
The NDA for SD-809 is based on results from two Phase III studies, ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia). A Priority Review is an expedited review granted by the FDA that allows for a faster evaluation of applications for drugs that could be significant improvements in the safety or effectiveness in the treatment of serious conditions. SD-809 was previously granted Breakthrough Therapy Designation by the FDA.
Comment:SD-809 is one of only four products in clinical development for tardive dyskinesia. Chief competitor is Neurocrine's VMAT2 inhibitor valbenazine (NBI-98854) in Phase III. The others are Medicure's MC-1 and Synchroneuron's controlled-release acamprosate, both at the Phase II stage.
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