New schizophrenia drug gets FDA approval, taking novel approach to treating brain disorder

A new drug has been approved for the treatment of schizophrenia in adults.

On Thursday, the U.S. Food and Drug Administration (FDA) approved COBENFY (xanomeline and trospium chloride), an oral medication that is manufactured by Bristol Myers Squibb in New Jersey.

This marks the first new class of medications for the brain disorder in several decades, according to a press release.

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COBENFY is expected to be available in the U.S. in late October, the company noted.

"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, PhD, board chair and chief executive officer at Bristol Myers Squibb, in the press release.

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Schizophrenia is a serious mental illness that affects a person’s thoughts, feelings and behaviors.

It often causes hallucinations, delusions, disordered speech and loss of touch with reality, Mayo Clinic states on its website.

The disorder can also lead to lack of emotional expression, lack of motivation, cognitive dysfunction and social withdrawal.

Approximately 2.8 million people in the U.S. and 24 million people globally are living with schizophrenia.

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The disorder has traditionally been treated with antipsychotic medications, but around 40% of patients do not respond to treatments and 60% experience "inadequate improvement" in symptoms or "intolerable side effects," studies have shown.

COBENFY works differently than the currently available schizophrenia medications.

"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 drug's clinical trials, in the release. 

"Schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies."

"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."

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Sam Clark, founder and CEO at Terran Biosciences — a biotech company that develops treatments and technologies for neurological and psychiatric diseases in New York City — commented on the new approval in a statement sent to Fox News Digital.

"I am excited that the FDA has just approved [COBENFY] as a treatment for patients with schizophrenia, marking a big leap forward in the psychiatry space," he said. 

"These patients live with a difficult disease, and this drug with a novel mechanism of action will surely make a significant impact," Clark continued. 

Since the 1950s, antipsychotics have primarily targeted dopamine receptors in the brain, he said.

"Cobenfy is the first with a new target — the muscarinic receptors," he said. "These receptors play an important role in maintaining many of the brain’s other neurotransmitter systems."

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"Cobenfy is also different in that it is a combination of two drugs — xanomeline, which exerts its beneficial effects in the brain, and trospium, which reduces side effects in the body."

The approval follows three phases of clinical trials in which COBENFY was shown to result in a "statistically significant improvement in illness."

In terms of safety, the medication’s most common side effects during clinical trials were nausea, indigestion, vomiting, diarrhea, constipation, hypertension, abdominal pain, accelerated heart rate, dizziness and gastroesophageal reflux disease, the release stated.

"Cobenfy is undoubtedly a major innovation, but it does have some unique limitations," Clark noted. 

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"It needs to be dosed twice daily, it cannot be taken with food, and it is not currently available as a long-acting injectable, which is often preferred by many patients."

With the FDA approval, Clark said he expects to see future improved versions of the drug to overcome these limitations.

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People should discuss potential complications with a doctor before starting the medication.

Fox News Digital reached out to Bristol Myers Squibb and the Schizophrenia & Psychosis Action Alliance requesting comment.

Melissa Rudy is senior health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.rudy@fox.com.