Cobenfy(xanomeline and trospium chloride)
Psychiatry· 2011 cited findings· 1 source document
Company: Bristol-Myers Squibb Company →
What the regulatory reviews say
Cobenfy (xanomeline and trospium chloride), also known as KarXT, is a capsule formulation administered twice daily. It is indicated for schizophrenia, as proposed by the applicant. The regulatory review completion date was 9/26/2024, resulting in an approval.
Efficacy was evaluated in three randomized, multicenter, double-blind, placebo-controlled clinical studies (KAR-007, KAR-009, KAR-004). The primary efficacy endpoint was the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 5, where Cobenfy demonstrated statistically significant superiority to placebo. Secondary endpoints, such as the Clinical Global Impression – Severity (CGI-S) score, were also statistically significant in KAR-007 and KAR-004, and nominally significant in KAR-009.
Safety data included 1614 subjects exposed to KarXT, with 336 exposed to the to-be-marketed dose for at least 6 months. In placebo-controlled studies, 4 deaths occurred in the KarXT group compared to 0 in the placebo group. Serious adverse events in short-term efficacy studies included one each of gastroesophageal reflux disease, suicidal ideation, and psychotic disorder. The maximum recommended dose for elderly patients is 100 mg/20 mg.
Key figures — cited to the source page
| PANSS total score change from baseline (KarXT) | -21.2 | Cobenfy FDA Review, p.53 |
| PANSS total score change from baseline (placebo) | -11.6 | Cobenfy FDA Review, p.53 |
| PANSS positive score change from baseline (KarXT) | -6.8 | Cobenfy FDA Review, p.55 |
| PANSS positive score change from baseline (placebo) | -3.9 | Cobenfy FDA Review, p.55 |
| PANSS negative score change from baseline (KarXT) | -3.4 | Cobenfy FDA Review, p.56 |
| Deaths in KarXT group | 4 | Cobenfy FDA Review, p.32 |
| Deaths in placebo group | 0 | Cobenfy FDA Review, p.32 |
| Review completion date | 9/26/2024 | Cobenfy FDA Review, p.2 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.