The U.S. FDA has approved Neurocrine Biosciences' Ingrezza capsules -- the first drug approved by the FDA to treat adults with tardive dyskinesia.
Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips.
The efficacy of Ingrezza, according to the FDA, was shown in a clinical trial of 234 participants that compared Ingrezza to placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received placebo.
Neurocrine’s label will not require a black box warning on depression and suicide -- which differentiates it from Teva's competitor treatment that is still awaiting FDA approval. Teva's Austedo was approved earlier this month for Huntington's therapy, and the drugmaker expects a tardive dyskinesia decision from the FDA by the end of August.
Read the FDA press release