Bristol Myers’ schizophrenia drug Cobenfy stumbles as adjunctive treatment, denting blockbuster plan

Title

Bristol Myers Squibb’s Schizophrenia Drug Cobenfy Falls Short as Add-on Therapy, Dampening Blockbuster Prospects

Keywords

Cobenfy
Bristol Myers Squibb
schizophrenia
adjunctive treatment
antipsychotics
Phase 3 trial
clinical trial failure
PANSS score
blockbuster drug
risperidone
drug approval

Key Facts

- Primary Endpoint Not Achieved:
Cobenfy (xanomeline and trospium chloride) failed to demonstrate a statistically significant improvement over placebo as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled schizophrenia at the primary six-week endpoint in Phase 3 trials. The change in PANSS score was not significant (P = 0.11)1 3 5.

- Numerical Improvement but Not Significant:
While Cobenfy plus an atypical antipsychotic showed a numerical reduction in symptom severity compared to placebo plus antipsychotic, the improvement did not reach statistical significance required for regulatory and clinical impact1 2 3 5.

- Subgroup Analysis Offers Limited Hope:
A post-hoc analysis indicated a notable difference in response in patients taking non-risperidone background antipsychotics, hinting at potential benefit in specific subgroups. However, further studies would be needed to support any new approvals based on these findings1 5.

- Safety Profile Consistent:
Cobenfy’s safety and tolerability profile as an adjunct was consistent with previous findings when used as monotherapy, suggesting no new safety concerns emerged in the adjunctive setting1 5.

- FDA Approval as Monotherapy Remains:
Cobenfy was previously approved by the FDA in 2024 as the first-in-class muscarinic agonist for adults with schizophrenia, based on monotherapy trials showing statistically significant reductions in symptoms4.

- Future Uncertain for Blockbuster Aspirations:
The failure in adjunctive therapy dents expectations for Cobenfy to become a blockbuster, as the latest results undermine the case for wider use alongside existing antipsychotics2 3 5.

- Historical Challenge:
Developing effective adjunctive therapies for schizophrenia remains challenging, with complex trial designs and the difficulty of showing added benefit over established antipsychotics5.