The US Food and Drug Administration (FDA) has approved the first medication for the treatment of tardive dyskinesia (TD), the agency said in a statement.
"[TD] can be disabling and can further stigmatize patients with mental illness," Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in the release. "Approving the first drug for the treatment of [TD] is an important advance for patients suffering with this condition."
The highly selective vesicular monoamine transporter 2 inhibitor valbenazine (Ingrezza, Neurocrine Biosciences) will be indicated for the treatment of adults with TD.
Today was the scheduled Prescription Drug User Fee Act date. Approval was based on positive results from several studies, including the Kinect 3 phase 3 trial of valbenazine vs placebo, which included 234 patients with moderate to severe TD plus schizophrenia, schizoaffective disorder, or a mood disorder.
The findings, which were published online last month in the American Journal of Psychiatry, showed that patients who received 80 mg/day of the active treatment had a significant decrease in TD symptoms on the Abnormal Involuntary Movement Scale (AIMS) at 6 weeks compared with those who received matching placebo, meeting the primary efficacy point.
The group receiving the treatment at 40 mg/day also had a reduction on the AIMS measures vs the placebo measures.
As reported by Medscape Medical News, positive topline results from Kinect 3 were first announced in 2015, with more detailed findings presented last year at the International Congress of Parkinson's Disease and Movement Disorders.
"A Welcome and Exciting Step"
Chronic exposure to dopamine receptor blockers, including antipsychotic medications, is thought to cause TD. According to the manufacturer, the condition is estimated to affect at least 500,000 people in the United States.
TD symptoms include uncontrollable movements in the tongue, face, trunk, and extremities and can sometimes interfere with walking, talking, and even breathing.
Neurocrine reported that there have now been 20 clinical trials of the drug with more than 1000 total participants. And although meaningful improvement was shown vs placebo through 6 weeks, there were also "continued reductions in TD observed through 48 weeks of treatment."
The FDA statement notes that treatment with valbenazine may cause serious adverse effects including sleepiness and QT prolongation. "Its use should be avoided in patients with congenital long QT syndrome or with abnormal heartbeats associated with a prolonged QT interval," the FDA statement said. "Those taking Ingrezza should not drive or operate heavy machinery or do other dangerous activities until it is known how the drug affects them."
"Until now, one of the few options for physicians when managing TD was to stop, change, or lower the dose of antipsychotic medication, potentially jeopardizing patients' psychiatric stability," Christoph U. Correll, MD, from Hofstra Northwell School of Medicine in Hempstead, New York, said in a release from the company.
However, the clinical trials showed that the drug reduced involuntary movements "without compromising underlying psychiatric care," added Dr Correll. "These results, combined with convenient once-daily dosing, represent a tremendous breakthrough."
"A treatment for [TD] is a welcome and exciting step in the continued effort to destigmatize mental health conditions," said Paul Gionfriddo, president and chief executive officer of Mental Health America, in the same release.
"With an FDA approved treatment now available, individuals and doctors can have more productive and proactive conversations about TD."
The drug received Breakthrough Therapy Designation from the FDA in 2014. It was also granted Fast Track and Priority Review designations.
It will "be in the distribution channel next week and will be available through a select pharmacy network," reports the manufacturer.
In addition, the drug is currently being investigated as a treatment for Tourette syndrome in adults and adolescents in two phase 2 trials and an open-label, rollover study.
"The often debilitating effects of [TD] have left people feeling isolated and forgotten," said Kevin C. Gorman, president and chief executive officer of Neurocrine, in a release. The new approval "represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope."
Cite this: FDA Approves First Treatment for Tardive Dyskinesia: Valbenazine (Ingrezza) - Medscape - Apr 11, 2017.