Allergan plc said Monday it has won U.S. Food and Drug Administration approval for use of Vraylar in the maintenance treatment of schizophrenia. The FDA approved the company’s supplemental new drug application for the substance, an antipsychotic that is already approved for the acute treatment of adult patients with manic or mixed episodes stemming from bipolar I disorder and for the treatment of schizophrenia. “Schizophrenia is one of the most challenging mental health disorders to manage — particularly due to the complexity of patient symptoms, varying response to treatment and high rates of relapse,” said Dr. Herbert Meltzer, professor of psychiatry and behavioral sciences at Northwestern Feinberg School of Medicine. “The goal of clinicians is to minimize relapses, which can cause significant personal distress, and can often have serious implications for a patient’s health.” Up to 70% of patients can experience relapse within one year of treatment without maintenance treatment, he said. Schizophrenia affects about 2.4 million American adults and symptoms include hallucinations, delusions, thought disorders and movement disorders. Allergan shares were flat premarket, but have fallen 18% in 2017, while the S&P 500 has gained 15%.
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