The US FDA approves a new schizophrenia drug

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

The company claims the new oral drug is the first new class of drugs in decades to offer a different approach by targeting specific receptors in the brain without interfering with dopamine pathways.

Schizophrenia is a mental disorder that affects the way a person thinks, feels, and behaves. Symptoms may include delusions, hallucinations, disorganized thinking, and dysfunction.

It typically occurs in late adolescence or early adulthood. Treatment often involves a combination of antipsychotics and therapy.

“Today's groundbreaking approval of our first-in-class treatment for schizophrenia represents an important milestone for the community where, after more than 30 years, there is now a completely new pharmacological approach to schizophrenia that has the potential to change the treatment paradigm,” said Chris Boerner, Chairman and CEO of Bristol Myers Squibb.

Schizophrenia is a serious mental illness that affects approximately 2.8 million people in the United States. Current treatments often result in inadequate symptom control or intolerable side effects.

Cobenfy was approved based on data from the EMERGENT clinical trials that showed a significant reduction in schizophrenia symptoms compared to placebo.

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

Cobenfy also showed an improvement in patients' overall disease severity over a five-week period.

Common side effects of the drug 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 disorder, and people often find themselves in a cycle of stopping and switching treatments,” said Rishi Kakar, chief scientific officer and medical director at Segal Trials and an investigator in the EMERGENT program.

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

Historically, most antipsychotics for schizophrenia target dopamine pathways, particularly the D2 receptors, to relieve symptoms.

However, this approach has limitations as many patients either do not 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 treat schizophrenia symptoms.

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