FDA accepts NDA for Karuna’s schizophrenia treatment
Betsy Goodfellow | November 30, 2023 | News story | Medical Communications | FDA, Karuna Therapeutics, NDA, Neurology, schizophrenia
Karuna Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adult patients.
The NDA has been given a Prescription Drug User Fee Act (PDUFA) date of 26 September 2024.
This submission follows data from the EMERGENT programme, which assessed the safety and efficacy of KarXT as a treatment for schizophrenia. EMERGENT-1, EMERGENT-2 and EMERGENT-3 compared the safety and efficacy of the drug compared to placebo, whereas EMERGENT-4 and EMERGENT-5 assessed its long-term safety.
The drug met its primary endpoint in all three placebo-controlled trials, demonstrating statistically significant and clinically meaningful improvements in symptoms of schizophrenia compared to the placebo. It was generally well-tolerated with most of the adverse effects being mild to moderate in severity.
Bill Meury, president and chief executive officer of Karuna Therapeutics, commented: “We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process. 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.”
Rishi Kakar MD, chief scientific officer and medical director of Segal Trials and investigator on the EMERGENT programme, added: “KarXT focuses on a novel pathway through muscarinic receptors to indirectly modulate dopamine signaling in key brain circuits, and in clinical trials completed to date KarXT has demonstrated the much-needed combination of strong tolerability and clinically meaningful symptom reduction. This decision by the FDA marks an important step in working toward a new chapter in the standard of care for those facing the immense, daily struggle of this serious mental illness.”
Betsy Goodfellow
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