Bristol Myers Squibb announced that the U.S. FDA has approved Cobenfy (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults, marking the first new drug for the disease in more than 30 years.
Cobenfy introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.
Schizophrenia is a persistent and often disabling mental illness affecting how a person thinks, feels and behaves. It is estimated to impact approximately 2.8 million people in the United States. Symptoms typically first appear in early adulthood and present differently in each person, making symptoms difficult to diagnose and manage. While the current standard of care can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy.
“For people living with schizophrenia, it's often difficult to find a treatment that works for them. Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition,” said Gordon Lavigne, chief executive officer of the Schizophrenia & Psychosis Action Alliance. “People living with schizophrenia want and deserve more. Today's approval provides a new option as people with schizophrenia move forward with proper support to rebuild their lives.”
The FDA approval of Cobenfy is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of Cobenfy for up to one year. In the phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five. The safety and tolerability profile of Cobenfy has been established across acute and long-term trials. In the phase 3 EMERGENT-2 and EMERGENT-3 trials, the most common adverse reactions were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness and gastroesophageal reflux disease. Cobenfy does not have atypical antipsychotic class warnings and precautions and does not have a boxed warning.
“Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies,” said Rishi Kakar, MD, chief scientific officer and medical director at Segal Trials and investigator in the EMERGENT program. “The approval of Cobenfy is a transformative moment in the treatment of schizophrenia because, historically, medicines approved to treat schizophrenia have relied on the same primary pathways in the brain. By leveraging a novel pathway, Cobenfy offers a new option to manage this challenging condition.”