Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its Vesicular Monoamine Transporter 2 inhibitor, NBI-98854, in tardive dyskinesia. A breakthrough therapy designation is granted for a drug that is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies. The breakthrough designation also allows intensive discussions with the FDA which are intended to expedite the development and review process of eligible drugs.
"We are pleased that after reviewing our dataset the FDA recognizes that NBI-98854 is potentially an important therapy for the treatment of tardive dyskinesia, and we look forward to working closely with the Division of Psychiatry to advance our development program," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences.
The Breakthrough Therapy Designation was granted, in part, based on the results of the Phase IIb Kinect studies of NBI-98854 in approximately 220 patients with tardive dyskinesia. Data from the Phase IIb program were presented in June 2014 at the Annual Congress of Parkinson's Disease and Movement Disorders in Stockholm, Sweden.
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