US FDA approves new schizophrenia drug

The US FDA has approved a new drug, Cobenfy, for treating schizophrenia in adults. This is a first new class for medication that targets specific brain receptors without affecting dopamine pathways.

In Short

• Cobenfy is the first new class of medicine to treat schizophrenia
• Schizophrenia is a mental health disorder that affects how a person thinks, feels, and behaves
• The new FDA-approved drug offers a new way to manage schizophrenia symptoms

The US 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 that the new oral medication is the first new class of medicine in decades to offer 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 can include delusions, hallucinations, disorganised thinking, and impaired functioning.

It typically emerges 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, there is now an entirely new pharmacological approach for schizophrenia, one that has the potential to change the treatment paradigm," said Chris Boerner, board chair and chief executive officer at Bristol Myers Squibb.

Schizophrenia is a serious mental illness affecting around 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 the EMERGENT clinical trials, which demonstrated significant reductions in schizophrenia symptoms compared to placebo.

In these Phase 3 trials, 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 illness severity over five weeks.

The common side effects of the drug include nausea, constipation, and dizziness, but 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 investigator in the EMERGENT program.

The expert said that the approval of Cobenfy is a "transformative moment" in treating schizophrenia because this medication uses a different mechanism in the brain than traditional treatments.

Historically, most antipsychotic drugs for schizophrenia have targeted dopamine pathways, specifically the D2 receptors, to manage symptoms.

However, this approach has limitations, as many patients either don’t respond well or experience significant side effects.

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

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