FDA approves new class of drugs for schizophrenia patients

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 manufactured by Bristol Myers Squibb in New Jersey.

According to a press release, this is the first new class of drugs against the brain disease in several decades.

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COBENFY is expected to be available in the United States by the end of October, the company announced.

“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 – one that has the potential to change the treatment paradigm.” said Chris Boerner, PhD, Chairman and CEO of 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.

Hallucinations, delusions, speech problems and loss of contact with reality are common, according to the Mayo Clinic website.

COBENFY (xanomeline and trospium chloride) is an oral medication manufactured by Bristol Myers Squibb in New Jersey. (Bristol Myers Squibb)

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

Approximately 2.8 million people in the United States and 24 million people worldwide live with schizophrenia.

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The disorder is traditionally treated with antipsychotic medications, but around 40% of patients do not respond to treatments and 60% experience “insufficient improvement” in symptoms or “unbearable side effects,” studies have shown.

COBENFY is expected to be available in the United States by the end of October, the company announced. (Bristol Myers Squibb)

COBENFY works differently than currently available schizophrenia medications.

“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, MD, chief scientific officer and medical director at Segal Trials and a researcher in the drug's clinical trials, in the Press release.

“Schizophrenia is not a one-size-fits-all disease, and people often find themselves in a vicious circle of stopping and changing treatment.”

“The approval of COBENFY is a turning point in the treatment of schizophrenia, as in the past the drugs approved to treat schizophrenia relied on the same primary signaling pathways in the brain.”

“By leveraging a novel pathway, COBENFY offers a new option for treating this challenging disease.”

“Today’s groundbreaking approval of our first-in-class treatment for schizophrenia represents an important milestone for the community,” said Chris Boerner, PhD, Chairman and CEO of Bristol Myers Squibb. (iStock)

Sam Clark, founder and CEO of Terran Biosciences – a biotech company developing 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 pleased that the FDA has just received approval [COBENFY] as a treatment for patients with schizophrenia, which represents a major advance in psychiatry,” he said.

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“These patients are living with a difficult disease, and this drug with a novel mechanism of action is sure to have a significant impact,” Clark continued.

“We look forward to continuing the renaissance as this approval paves the way for future breakthroughs and novel patient-focused therapeutics.”

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The approval follows three phases of clinical trials in which COBENFY was shown to result in “statistically significant improvement in disease.”

Schizophrenia is a serious mental illness that affects a person's thoughts, feelings, and behaviors, often causing hallucinations and delusions. (iStock)

In terms of safety, the drug's most common side effects during clinical trials were nausea, indigestion, vomiting, diarrhea, constipation, high blood pressure, abdominal pain, rapid heart rate, dizziness and gastroesophageal reflux disease, the release said.

Other, more serious risks may exist in patients with certain existing medical conditions.

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People should discuss possible complications with a doctor before starting to take the medication.

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