Bristol-Myers Squibb Company — Cobenfy FDA Review (NDA216158, ORIG 1, 2024)

Bristol-Myers Squibb Company · 2024 · FDA Review (openFDA) · company profile →

Report summary

The FDA recommends approval for Bristol-Myers Squibb's Cobenfy (xanomeline tartrate and trospium chloride) for adult schizophrenia, with a PDUFA goal date of September 26, 2024. Efficacy was demonstrated in three short-term studies (KAR-007, KAR-009, KAR-004), showing significant improvements in PANSS total and CGI-S scores. Key safety concerns include liver enzyme elevations and urinary retention, which are deemed manageable through labeling and postmarketing requirements. While the drug is associated with common adverse events like nausea, vomiting, and hypertension, it does not significantly impact metabolic parameters or prolactin. Cobenfy is not recommended for moderate to severe renal or any hepatic impairment due to increased exposure. The review also highlights the importance of administering the drug at least 1 hour before or 2 hours after meals due to food-related reductions in trospium exposure.

Key findings — cited to the page

Established/proper name	Xanomeline and trospium chloride	· p.2
Proposed proprietary name	Cobenfy	· p.2
Other product name	KarXT	· p.2
Dosage form	Capsule	· p.2
Dosing regimen	Twice daily	· p.2
Applicant-proposed indication	Schizophrenia	· p.2
Regulatory action	Approval	· p.2
Approved dosage	50 mg/20 mg daily starting dose titrated up to 100 mg/20 mg or 125 mg/30 mg daily	· p.2
Approved indication	Treatment of schizophrenia in adults	· p.2
Number of randomized, placebo-controlled, double-blind clinical studies	3	· p.26
Phase 3 studies	KAR-007, KAR-009	· p.26
Review completion date	9/26/2024	· p.2

Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →