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

The company claims the new oral drug is the first new class of drug 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 the way a person thinks, feels, and behaves. Symptoms may include delusions, hallucinations, disorganized 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 historic approval of our first-in-class treatment for schizophrenia is an important milestone for the community where, after more than 30 years, there is now an entirely new pharmacological approach to schizophrenia that is poised to change the treatment paradigm. Has the ability to.” said Chris Boerner, Chairman of the Board and Chief Executive Officer of Bristol Myers Squibb.

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

Cobenfi was approved based on data from emergency clinical trials, which showed a significant reduction in schizophrenia symptoms compared to placebo.

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

Cobenfi also showed improvements in patients’ overall disease severity over five weeks.

Common side effects of the drug include nausea, constipation, and dizziness, but there are no serious warnings associated with atypical antipsychotics.

“Because of its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in cycles of stopping and changing treatments,” said Rishi Kakar, M.D., chief scientific officer and medical director of SEGAL Trials and investigator. In a casual event.

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

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

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

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

To further support patients, Bristol Myers Squibb has launched a program called Cobenfi Cares, which provides resources and support to those prescribed the drug.