INGREZZA Significantly Reduced the Symptoms of Involuntary Movements in Patients with Bipolar or Major Depressive Disorder in Post-Hoc Analysis. Patients Treated with INGREZZA Able to Remain on Existing Psychiatric Medications.
January 16, 2019, SAN DIEGO, CA—Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that a new analysis of INGREZZA® (valbenazine) capsules, published in the Journal of Affective Disorders1, demonstrated sustained improvement in tardive dyskinesia (TD) symptoms in patients with primary mood disorders. In the post-hoc analysis, INGREZZA significantly reduced involuntary movements associated with TD in patients with a primary mood disorder, such as bipolar and major depressive disorder, and was generally well tolerated with no clinically meaningful changes to psychiatric stability. INGREZZA is the first U.S. Food and Drug Administration (FDA) approved treatment for adults with TD, a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts.
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from INGREZZA and the continued success of the launch of INGREZZA. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: the Company's future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA, including the likelihood of continued revenue and prescription growth of INGREZZA; risks and uncertainties relating to factors that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA may be precluded from commercialization or continued commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2018. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.