FDA Oks Neurocrine's Ingrezza Capsules To Treat Adults With Tardive Dyskinesia

(RTTNews) - Neurocrine Biosciences Inc. (NBIX) said that the U.S. Food and Drug Administration has approved INGREZZA or valbenazine capsules for the treatment of adults with tardive dyskinesia or TD.

NBIX closed Tuesday's regular trading at $41.48, up $1.17 or 2.90 percent. In the after-hours trade, the stock gained $8.02 or 19.33 percent.

INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product indicated for the treatment of adults with TD.

The company noted that INGREZZA will be in the distribution channel next week and will be available through a select pharmacy network. Promotion to healthcare professionals will commence on May 1, 2017.

Tardive dyskinesia is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. The condition is caused by treatments that block dopamine receptors in the brain, such as antipsychotics and other medications, which are commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression.

In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect at least 500,000 people in the U.S.

The FDA warned that Ingrezza may cause serious side effects including sleepiness and heart rhythm problems (QT prolongation). Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval. Those taking Ingrezza should not drive or operate heavy machinery or do other dangerous activities until it is known how the drug affects them.