FDA Approves First Drug to Treat Neurologic Condition

Yesterday, the FDA approved valbenazine (Ingrezza) capsules to treat patients with tardive dyskinesia (TD). Valbenazine is a selective vesicular monamine transporter 2 inhibitor, and is the first drug approved to treat adults with TD.

TD is a neurological disorder where patients experience involuntary movement of the jaw, lips, and tongue, including grimacing, sticking out the tongue, and smacking the lips, according to a press release. These patients may also experience involuntary movement of arms and legs, and trouble with breathing.

"Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness," said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition."

This condition is a side effect seen among some patients who have been treated with antipsychotics, especially older medications. These patients were typically treated for a long period of time to treat schizophrenia, bipolar disorder, depression. It can also occur in patients taking medication for gastrointestinal disorders, according to the FDA. It is currently unknown why some patients taking the medications develop TD, while others are unaffected.

TD is typically treated by stopping, changing, or lowering doses of antipsychotics, which may put the patient at risk.

"The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of Ingrezza represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope," said Kevin C. Gorman, CEO of Neurocrine Biosciences. "For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of TD have access to Ingrezza."

The efficacy of valbenazine was evaluated in a phase 3 clinical trial of 234 patients with TD who were randomized to receive the drug or placebo. Researchers discovered that after 6 weeks of treatment, patients taking valbenazine had improvement in the severity of involuntary movements, compared with placebo patients.

Neurocrine reported that the drug was generally well tolerated, and no patients showed a worsening of depression, suicidal ideation or suicidal behaviors.

"A treatment for tardive dyskinesia is a welcome and exciting step in the continued effort to destigmatize mental health conditions," said Paul Gionfriddo, president & CEO of Mental Health America. "With an FDA approved treatment now available, individuals and doctors can have more productive and proactive conversations about TD.”

Valbenazine may cause sleepiness and QT prolongation, and should not be taken by patients with congenital long QT syndrome, or those with abnormal heartbeat associated with prolonged QT interval, the FDA warned.

"The FDA's approval of Ingrezza represents the culmination of over 10 years of dedicated effort from the Neurocrine research and development teams," said Christopher F. O'Brien, MD, chief medical officer at Neurocrine's "Neurocrine would like to thank the many clinical investigators and TD patients who participated in our clinical trials. Without their partnership and commitment, we would not have been able to achieve this tremendous breakthrough."