The valbenazine therapy was indicated for 80 mg capsule therapy by the FDA.
Treatment options for tardive dyskinesia (TD) continue to exponentially grow in 2017.
Valbenazine (Ingrezza), the first US Food and Drug Administration (FDA) approved treatment for the antipsychotic medication-induced movement disorder, was indicated for varied dosing rates last week.
The FDA approved 80 mg Ingrezza capsules for the treatment of adult patients with TD. Functioning as a vesicular monoamine transporter (VMAT)-2, 80 mg Ingrezza can pair as a once-daily therapy combined with psychiatric medications.
Kevin C. Gorman, chief executive officer of Neurocrine Biosciences, called Ingrezza the continued “TD treatment of choice.”
“With the approval of the new 80 mg capsule, patients now have access to an even more convenient treatment option,” Gorman said. “Ingrezza is the only TD therapy to offer simplified dosing with only 1 capsule once per day."
As 80 mg capsules, Ingrezza reported significant and rapid improvement versus placebo at 6 weeks in clinical trials. Separation between therapy and placebo patient groups was noted as soon as week 2, and continued reductions in condition effects were documented through 48 weeks of treatment.
Somnolence was the only adverse event to occur at a rate of at least 5 percent and twice placebo. There was no general worsening in depression, suicidal ideation or behaviors safety scale scores during clinical trials.
As of the current Ingrezza dosing approval, the treatment has been studied in more than 1,000 individuals through 20-plus clinical trials. Chris O’Brien, MD, chief medical officer at Neurocrine, told MD Magazine at the time of Ingrezza’s approval that the concept of the drug was formed a decade ago.
“We knew more than ten years ago that targeting this protein in the brain called VMAT2 could help regulate the dysfunctional movement control system in the basil ganglia,” O’Brien said. “What we had to do was come up with a molecule that did that and only that.”
Coming into the market with the first promising TD therapy, O’Brien said Ingrezza had administrative support.
“I have to say as a neurologist who works in drug discovery and development, I’ve worked with the FDA on a number of different projects over the years,” O’Brien said. “In this situation, the division of psychiatric products at the FDA was very engaged. They were absolutely committed to help get a treatment to patients.”