Xanomeline

FDA approves COBENFY, a new oral medication for schizophrenia in adults, marking the first new class of drugs for the disorder in decades. COBENFY, manufactured by Bristol Myers Squibb, is expected to be available in the U.S. in late October and works through a novel pathway in the brain, offering a new treatment option for patients.

Bristol-Myers Squibb's $14 billion acquisition of Karuna Therapeutics pays off with FDA approval for Cobenfy, a novel schizophrenia drug targeting cholinergic receptors. Cobenfy offers a new treatment approach with milder side effects compared to dopamine-blocking drugs, potentially leading to blockbuster sales. BMS plans to launch Cobenfy at $1,850 per month, with further clinical trials underway for additional indications.

FDA approved BMS's Cobenfy, a first-in-class cholinergic receptor-targeting treatment for schizophrenia in adults, based on two 5-week, randomized, double-blind, placebo-controlled studies showing significant symptom reduction. Cobenfy offers a new pharmacological approach, potentially changing the treatment paradigm for schizophrenia, though it carries risks of urinary retention, increased heart rate, and liver damage.

FDA approves Cobenfy (xanomeline and trospium chloride), the first new class of medicine in decades for treating schizophrenia, targeting cholinergic receptors instead of dopamine receptors.

The FDA approved xanomeline and trospium chloride (Cobenfy) for schizophrenia in adults, marking the first new drug class for the condition in over 30 years. Unlike antipsychotics, Cobenfy targets M1 and M4 muscarinic receptors, potentially benefiting patients who do not respond to dopamine-blocking agents. The drug showed significant reductions in Positive and Negative Syndrome Scale (PANSS) scores in phase III trials and has fewer common side effects compared to typical schizophrenia agents. Cobenfy is contraindicated in certain patient groups and should be discontinued if liver disease symptoms appear. It is expected to launch in late October.

FDA approved Cobenfy, a new schizophrenia treatment targeting the cholinergic system, after 30 years without new options. Developed by Karuna Therapeutics and acquired by Bristol Myers Squibb, Cobenfy aims to reduce symptoms like hallucinations and delusions with fewer side effects compared to dopamine-based treatments.

FDA approved xanomeline and trospium chloride (Cobenfy) for schizophrenia, marking the first new class of medication in decades. The drug targets M1 and M4 receptors without blocking D2 receptors, supported by EMERGENT clinical program data showing significant symptom reduction. Common side effects include nausea and hypertension.

FDA approves Cobenfy, a new schizophrenia treatment combining xanomeline and trospium chloride, targeting cholinergic receptors, offering a new alternative to traditional antipsychotics.

Bristol-Myers Squibb's COBENFY, a new schizophrenia treatment, received FDA approval, marking the first new pharmacological approach in decades. The drug targets M1 and M4 receptors, with a favorable safety profile and potential peak sales of $4.2 billion.

BMS’s new schizophrenia drug Cobenfy, approved by FDA, offers a unique treatment option but won’t see significant acceleration until mid-next year. Success hinges on market access and indication expansion.