Neurocrine Biosciences, Inc. announced that the U.S. FDA has approved INGREZZATM (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD).
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 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, Chief Executive Officer 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.""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," said Christoph U. Correll, MD, Professor, Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine. "In clinical trials, INGREZZA significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD."
Clinical studies have shown that INGREZZA provides significant, rapid and meaningful improvement in TD signs and symptoms compared to placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment. INGREZZA was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5 percent and twice placebo. In clinical trials, no worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. INGREZZA has been studied in over 1,000 individuals and more than 20 clinical trials.
"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."
"The FDA's approval of INGREZZA represents the culmination of over ten years of dedicated effort from the Neurocrine research and development teams," said Christopher F. O'Brien, MD, Neurocrine's Chief Medical Officer. "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."
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. To assist TD patients in gaining access to INGREZZA, Neurocrine has created the INBRACETM patient support program, which will immediately begin accepting treatment initiation forms from health care professionals prescribing INGREZZA and work closely with patients and their families to facilitate access. INBRACE is designed to provide personalized product assistance and services. For more information, patients may visit www.INGREZZA.com or call 1-84-INGREZZA (1-844-647-3992).
About Neurocrine Biosciences
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA™ (valbenazine), a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette Syndrome.
Neurocrine Biosciences, Inc. news releases are available through the Company's website at http://www.neurocrine.com.