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Data shows long-term efficacy, safety of Ingrezza for tardive dyskinesia

Full long-term findings, indicating efficacy and safety of Ingrezza for tardive dyskinesia, were recently published in Journal of Clinical Psychiatry, according to Neurocrine Biosciences Inc.

Ingrezza (valbenazine, Neurocrine Biosciences) was approved by the FDA in April and long-term data were first presented at the American Psychiatric Annual Meeting in San Diego in May.

“In two 6-week, double-blind, placebo-controlled clinical trials (KINECT 2, NCT01733121; KINECT 3, NCT02274558), treatment with once-daily valbenazine resulted in significant improvement of [tardive dyskinesia] compared to placebo. Short-term treatment with valbenazine was generally well tolerated, and stable psychiatric status was maintained in both [double-blind, placebo-controlled] studies,” Stewart A. Factor, DO, of Emory University School of Medicine, and colleagues wrote.

To determine long-term efficacy of valbenazine for tardive dyskinesia, researchers conducted a 42-week valbenazine extension phase and subsequent 4-week washout period among participants who completed the 6-week double-blind, placebo-controlled period of KINECT 3. Participants who received placebo previously were re-randomized to receive 80 mg or 40 mg of valbenazine while others continued to receive valbenazine at their KINECT 3 dose.

Overall, 198 participants entered the valbenazine extension phase, 124 completed treatment at week 48, and 121 completed the follow-up visit after washout at week 52.

During the valbenazine extension phase, 69.2% of participants had at least one treatment-emergent adverse event; 14.6% had serious treatment-emergent adverse events; and 15.7% discontinued due to treatment-emergent adverse events.

During washout, 13.1% of participants experienced a treatment-emergent adverse event.

Researchers did not find risk for suicidal ideation or behavior.

Long-term valbenazine did not induce or worsen akathisia or parkinsonism, according to researchers.

Generally, participants maintained psychiatric stability during the study.

Abnormal Involuntary Movement Scale and Clinical Global Impression of Change-Tardive Dyskinesia scores showed sustained improvement in tardive dyskinesia. Scores returned toward baseline after 4 weeks of valbenazine washout.

“We are pleased with the long-term data, which demonstrate the ability of Ingrezza to effectively improve the symptoms of tardive dyskinesia with durable response,” Christopher O’Brien, MD, chief medical officer of Neurocrine Biosciences, said in a press release. “The data also showed that Ingrezza was generally well-tolerated and did not interfere with the effects of concomitant antipsychotic and antidepressant medications.” – by Amanda Oldt

Disclosures: Factor reports receiving honoraria from Neurocrine Biosciences, Lundbeck, Auspex/Teva, Avanir, Cynapsus, Adamas, and UCB; grants from Ipsen, Medtronics, Teva, US World Meds, Pharm-Olam, Cynapsus Therapeutics, Solstice, Vaccinex, CHDI Foundation, Michael J. Fox Foundation, and NIH; and royalties from Blackwell Futura, Demos, and UpToDate. Please see the full study for a list of all other authors’ relevant financial disclosures.