The US FDA approves a new schizophrenia drug

The U.S. Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Cobenfy drug (xanomeline and trospium chloride) for the treatment of schizophrenia in adults.

The company claims the new oral medication is the first new class of drugs in decades that offers a different approach by targeting specific receptors in the brain without affecting dopamine pathways.

Schizophrenia is a mental disorder that affects how a person thinks, feels and behaves. Symptoms may include delusions, hallucinations, disorganized thinking, and impaired functioning.

It usually develops in late adolescence or early adulthood. Treatment often involves a combination of antipsychotic medications and therapy.

“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, an entirely new pharmacological approach to schizophrenia now exists, one that has the potential to change the treatment paradigm,” says Chris Boerner , Chairman and CEO of Bristol Myers Squibb.

Schizophrenia is a serious mental illness that affects approximately 2.8 million people in the US, with current treatments often resulting in inadequate symptom control or intolerable side effects.

Cobenfy was approved based on data from EMERGENT’s clinical trials, which showed a significant reduction in symptoms of schizophrenia compared to placebo.

In these Phase 3 studies, patients treated with Cobenfy showed substantial improvement in their condition as measured by the Positive and Negative Syndrome Scale (PANSS).

Cobenfy also showed improvement in patients’ overall disease severity over five weeks.

The drug’s common side effects include nausea, constipation, and dizziness, but there are no serious warnings associated with atypical antipsychotics.

“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, chief scientific officer and medical director at Segal Trials and researcher. in the EMERGENT program.

The expert said the approval of Cobenfy is a “transformative moment” in the treatment of schizophrenia because this drug uses a different mechanism in the brain than traditional treatments.

Historically, most antipsychotic medications for schizophrenia have targeted dopamine pathways, particularly the D2 receptors, to control symptoms.

However, this approach has limitations, as many patients do not respond well or experience significant side effects.

Cobenfy, on the other hand, targets the M1 and M4 receptors in the brain, offering a new way to manage schizophrenia symptoms.

To further support patients, Bristol Myers Squibb has launched Cobenfy Cares, a program that provides resources and assistance to those prescribed the medication.