Prodrugs and patents: Enhancing therapy adherence and reducing side effects
Bristol Myers Squibb's schizophrenia drug KarXT, with a PDUFA date of 26 September 2024, shows strong clinical data and a differentiated mechanism. Concerns over its twice-daily dosing led Terran Biosciences to develop a once-daily oral and multi-month injectable prodrug version, TerXT and TerXT LAI, aiming to improve adherence. KarXT's potential to avoid traditional antipsychotic side effects like weight gain and diabetes risks is highlighted, with GlobalData forecasting $2.99bn in sales by 2030.
Related Clinical Trials
Reference News
FDA approves Cobenfy, first new schizophrenia drug in over 30 years, combining xanomeline and trospium chloride to manage symptoms via a different mechanism targeting acetylcholine, potentially reducing common side effects like weight gain and drowsiness.
FDA approves KarXT, a new schizophrenia treatment by Bristol Myers Squibb, offering improved symptoms and fewer side effects. KarXT, a combination of Xanomeline and trospium, targets muscarinic receptors and reduces digestive issues. The drug is expected to be cost-effective if priced between $16,000 and $20,000 per year, with 75% of patients seeing symptom improvement by 30% or more after one year.
The FDA approved Cobenfy, a new antipsychotic medication for schizophrenia, developed by Karuna Therapeutics. Despite its efficacy in clinical trials, concerns about insurance coverage and high list price ($22,500/year) may limit patient access. Bristol Myers Squibb, which acquired Karuna, plans to expand Cobenfy's use to bipolar disorder and Alzheimer's agitation, with ongoing studies.
The FDA approved Cobenfy, the first oral schizophrenia drug targeting cholinergic receptors, offering a new treatment alternative. Schizophrenia affects 1% of the U.S. population, with 5% dying by suicide. MRI scans focusing on neuromelanin predict treatment resistance, and consistent sleep is crucial for patients.
The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.
KarXT, developed by Karuna Therapeutics, expected to receive FDA approval on Sept. 26, marking the first novel schizophrenia drug in over 70 years. Bristol-Myers Squibb acquired Karuna for $14 billion in 2023. Existing treatments often have serious side effects, and high drug pricing could limit KarXT's accessibility. AbbVie acquired Cerevel Therapeutics for $8.7 billion in August. Experts emphasize systemic changes are needed for effective mental health care.
FDA approves Cobenfy, a first-in-class treatment for schizophrenia, offering a new pharmacological approach. Cobenfy, combining xanomeline and trospium chloride, demonstrated significant symptom reduction in trials, with common adverse reactions including nausea and hypertension. The approval aims to transform schizophrenia treatment by leveraging a novel pathway in the brain.
The FDA approved xanomeline and trospium chloride capsules (Cobenfy) for schizophrenia, marking the first new pharmacological approach since the 1970s. The drug, a dual M1/M4 muscarinic acetylcholine receptor agonist, offers a new treatment alternative without common adverse events like weight gain or movement disorders, based on phase 3 EMERGENT trials.
FDA approves Bristol Myers Squibb's Cobenfy, the first novel schizophrenia treatment in over 70 years, expected to be available in late October. The twice-daily pill, acquired from Karuna Therapeutics for $14 billion, offers a new mechanism of action without direct dopamine blocking, aiming to reduce side effects. Cobenfy's annual cost is $22,500, with a program to aid affordability. The drug may also be tested for Alzheimer's psychosis, bipolar mania, and autism-related irritability.
Bristol Myers Squibb's schizophrenia drug KarXT, with a PDUFA date of 26 September 2024, shows strong clinical data and a differentiated mechanism. Concerns over its twice-daily dosing led Terran Biosciences to develop a once-daily oral and multi-month injectable prodrug version, TerXT and TerXT LAI, aiming to improve adherence. KarXT's potential to avoid traditional antipsychotic side effects like weight gain and diabetes risks is highlighted, with GlobalData forecasting $2.99bn in sales by 2030.
The FDA is set to share results on Bristol Myers Squibb’s KarXT for schizophrenia, which targets muscarinic receptors. KarXT, a combination of xanomeline and trospium, shows potential as a breakthrough treatment with a unique mechanism and fewer adverse effects. The approval could lead to further innovations in schizophrenia treatment, aiming for safer, more effective, and easier-to-use medications.
The FDA approved Cobenfy, a new schizophrenia treatment targeting muscarinic receptors, developed by Karuna Therapeutics and sold by Bristol Myers Squibb.
Bristol-Myers Squibb's novel schizophrenia drug, Cobenfy, received FDA approval. Cobenfy, the first non-dopamine blocking treatment, aims to reduce side effects. Acquired from Karuna Therapeutics for $14 billion, the twice-daily pill will cost $1,850 monthly. BMY stock rose 4.35% to 52.30, signaling a breakout.
KarXT, a new antipsychotic targeting muscarinic receptors, received US approval, offering potential for more effective and better-tolerated schizophrenia treatment. It modulates dopamine release and improves cognitive function without severe side effects, marking a shift in psychosis treatment. Future drugs may further refine this approach, tailoring treatment to individual needs.
The FDA will respond to the New Drug Application for Bristol Myers Squibb and Karuna Therapeutic’s schizophrenia drug, KarXT, by September 26, 2024. KarXT, a muscarinic M1/M4 agonist, shows promise in reducing schizophrenia symptoms without metabolic, endocrine, or motor adverse effects, potentially positioning it as a first-line treatment alongside standard serotonin/dopamine antagonists.
FDA expected to approve KarXT, the first new schizophrenia drug in decades, known for effectiveness and milder side effects.
FDA may approve KarXT, a novel antipsychotic for schizophrenia, potentially the first new treatment in 70 years. KarXT combines xanomeline and trospium to target brain receptors, reducing acute psychotic symptoms with fewer side effects. However, concerns include potential cardiovascular risks, unclear long-term efficacy, and high cost.
Nature Reviews Drug Discovery (Nat Rev Drug Discov) has online ISSN 1474-1784 and print ISSN 1474-1776.