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Karuna Therapeutics’ NDA submitted to FDA for schizophrenia treatment
Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia.
The NDA submission is supported by safety and efficacy data from the EMERGENT programme, which assessed KarXT as a treatment for schizophrenia. This programme includes three completed positive trials, EMERGENT-1, EMERGENT-2 and EMERGENT-3, and the ongoing EMERGENT-4 and EMERGENT-5 trials assessing the drug’s long-term safety.
In the three completed trials, KarXT met its primary endpoint, and demonstrated a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo. The drug also met its secondary endpoints of reductions in both positive and negative symptoms of schizophrenia as measured by PANSS positive, PANSS negative and PANSS negative Marder factor subscales, in all three completed trials.
The drug was generally well tolerated with most adverse events being cholinergic in nature and rated mild to moderate in terms of severity.
Bill Meury, president and chief executive officer of Karuna Therapeutics, commented: "Schizophrenia is a serious mental illness that affects how one thinks, feels and behaves, with symptoms often appearing in patients in early adulthood, during the prime years of their lives. While current therapies have made a difference for many patients, they are not without limitations due to lack of full symptom relief or side effects that may lead to treatment discontinuation. KarXT, if approved, will represent the first novel pharmacological approach to treating schizophrenia in several decades and provide a new treatment option for patients and their physicians.”
Meury continued: “The NDA submission represents an important step toward helping patients in need. It is also a defining moment for Karuna Therapeutics. It represents the culmination of years of preclinical and clinical development, and a great deal of skill and hard work by our R&D organisation. Our priorities over the next year are the regulatory review process, our ongoing development efforts, and building the platform to introduce KarXT to the medical community. I believe we are uniquely positioned to make a positive impact on how neuropsychiatric conditions are treated.”