Cobenfy Did Not Meet Primary Outcome as Add-On Treatment for Schizophrenia
However, the results show that there was an improvement of symptom scores, although they were not significant.
Xanomeline and trospium chloride (Cobenfy) demonstrated a 2-point reduction in Positive and Negative Syndromes Scale (PANSS) total score as an adjunct to atypical antipsychotics in adults with inadequately controlled schizophrenia, which did not meet the statistical significance for the primary end point, according to results from the phase 3 ARISE (NCT05145413) trial. According to the data, Cobenfy as an adjunctive treatment was associated with improved symptoms compared to the placebo and atypical antipsychotics for certain patients receiving risperidone.1
However, the results show that there was an improvement of symptom scores, although they were not significant. | Image Credit: melita - stock.adobe.com
"Adjunctive treatment trials in schizophrenia present significant clinical and methodological challenges," Husseini Manji, MD, FRCPC, co-chair of the UK Government Mental Health Goals Program and professor in the department of psychiatry at Oxford University, said in a news release.1 "When patients are already receiving treatment, demonstrating additional statistical benefit becomes inherently more difficult . . . Although Cobenfy did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, the data are encouraging, showing a noteworthy improvement for the majority of patients in the trial, as well as a tolerable safety profile. These findings warrant additional follow-up and may provide valuable direction in our ongoing search for complementary approaches to address these persistent treatment gaps."
In the 6-week trial, investigators aimed to assess Cobenfy for patients with an inadequate response to their current atypical antipsychotic treatment. The primary objective was to assess the efficacy of the drug twice daily compared with the placebo measures by PANSS total score. Patients included were aged 18 to 64 years, had a primary diagnosis of schizophrenia, and were currently being treated with a monotherapy of risperidone, paliperidone, aripiprazole, or long-acting injectables, such as ziprasidone, lurasidone, or cariprazine. Secondary outcomes included change in baseline for personal social performance, change in clinical global impression-severity, change in positive symptom factor score of PANSS, change in negative symptom factor score of PANSS, response defined by the proportion of subjects having a 30% or more improvement in PANSS, and preference of medication.2
The FDA approved Cobeny in 2024 as an oral medication for the treatment of schizophrenia in adults. The approval was marked as a major breakthrough for the mental health condition and the first in a new class of medication.3
"Historically, the development of an effective, adjunctive treatment for schizophrenia has been difficult due to inherent challenges like variable patient response, stringent trial design requirements, and the complexities of demonstrating incremental benefits beyond established antipsychotics," Samit Hirawat, MD, executive vice president, chief medical officer, and head of development at Bristol Myers Squibb, said in the news release.1 "While the primary endpoint in this trial did not meet statistical significance, we need to complete our analysis and will plan to engage with the medical community and regulators to discuss these results and potential next steps.”
READ MORE: Mental and Behavioral Health Resource Center
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