Here are some updates from the world of psychiatry throughout the month of November.
Here’s some news you may have missed in the world of psychiatry from throughout the month of November, as featured in Psychiatric Times®.
FDA Accepts NDA, Grants PDUFA Date for Investigational Schizophrenia Treatment
Karuna Therapeutics announced that the US Food & Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults and granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.
“We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process,” said Bill Meury, president and chief executive officer at Karuna Therapeutics, in a press release. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia.” Continue Reading
Study Finds That Long-Acting Schizophrenia Treatment Prolongs Time to Impending Relapse
Results from the Risperidone Subcutaneous Extended-Release (RISE) study have been released, indicating that the treatment under investigation significantly prolonged the time to impending relapse in patients with schizophrenia.
The RISE study—a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial—sought to evaluate the potential of Uzedy, a formulation of risperidone, as a long-acting injectable (LAI) antipsychotic treatment for adults with schizophrenia. The RISE study included 544 patients who were randomly assigned to receive a subcutaneous injection of Uzedy once every month (n=183) or once every 2 months (n=180), or a placebo (n=181). Continue Reading
Positive Data for First and Only Treatment Approved for Agitation in Alzheimer Dementia
Recently released positive phase 3 trial data of brexpiprazole (Rexulti)—the first and only treatment approved to treat agitation associated with dementia due to Alzheimer disease—showed it reduced agitation in Alzheimer dementia significantly in 3 agitation symptoms categories: aggressive behaviors, physically nonaggressive behaviors, and verbally agitated behaviors.
“Treatment of agitation is essential to increase the comfort, quality of life, and safety of patients with Alzheimer dementia; to ease the burden on their caregivers; and to allow patients to live at home longer,” wrote the authors. Continue Reading
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