A new drug has been approved to treat schizophrenia in adults.
On Thursday, the U.S. Food and Drug Administration (FDA) approved COBENFY (xanomeline and trospium chloride), an oral drug manufactured by Bristol-Myers Squibb of New Jersey.
According to a press release, this is the first new class of treatment for brain disorders in decades.
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COBENFY is expected to be available in the U.S. in late October, the company said.
A new drug has been approved to treat schizophrenia in adults. (St. Petersburg)
“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community. An approach has been born that has the potential to change the treatment paradigm,'' said Dr. Chris Werner, Chairman and Chief Executive Officer of Bristol-Myers Squibb, in a press release.
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Schizophrenia is a serious mental illness that affects a person's thoughts, feelings, and behavior.
The Mayo Clinic says on its website that it often causes hallucinations, delusions, speech problems and a loss of sense of reality.
COBENFY (xanomeline and trospium chloride) is an oral medication manufactured by Bristol-Myers Squibb Company of New Jersey. (Bristol-Myers Squibb)
The disorder can also cause 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 have schizophrenia.
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The disorder has traditionally been treated with antipsychotic drugs, but approximately 40% of patients do not respond to treatment and 60% experience “inadequate improvement” in symptoms or “unbearable side effects.” Research shows that there is.
COBENFY is expected to be available in the U.S. in late October, the company said. (Bristol-Myers Squibb)
COBENFY works differently than currently available schizophrenia drugs.
Rishi Kakkar, M.D., Chief Scientific Officer and Medical Director of Segal Trials, said, “Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all disease and is prone to cycles of stopping and switching treatments.'' It happens often,” he said. The statement also included researchers working on the drug's clinical trials.
“Schizophrenia is not a one-size-fits-all disease, and treatment is often stopped and switched.”
“Historically, drugs approved to treat schizophrenia have relied on the same primary pathways in the brain, so the approval of COBENFY is a transformative moment in the treatment of schizophrenia.”
“By leveraging new pathways, COBENFY offers new options for managing this difficult condition.”
“Today's landmark approval of our first-in-class treatment for schizophrenia is an important milestone for the community,” said Dr. Chris Werner, Chairman and Chief Executive Officer of Bristol-Myers Squibb. ''. (St. Petersburg)
Sam Clark, founder and CEO of Terran Biosciences, a New York City-based biotechnology company developing treatments and technologies for neurological and psychiatric disorders, said in a statement to Fox News Digital. commented on this new approval.
“We are thrilled that the FDA has approved it.” [COBENFY] “Using it as a treatment for patients with schizophrenia would be a major advance in the field of psychiatry,” he said.
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“These patients are living with difficult diseases, and this drug with its novel mechanism of action will undoubtedly have a major impact,” Clark continued.
“We look forward to the continued renaissance as this approval paves the way for future breakthroughs and new patient-centered treatments.”
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The approval follows a three-stage clinical trial in which COBENFY was shown to produce “statistically significant disease improvement.”
Schizophrenia is a serious mental illness that affects a person's thoughts, feelings, and behavior, often causing hallucinations and delusions. (St. Petersburg)
In terms of safety, the most common side effects of this drug during clinical trials were nausea, indigestion, vomiting, diarrhea, constipation, high blood pressure, abdominal pain, increased heart rate, dizziness, and gastroesophageal reflux disease, the release said. is stated.
Patients with certain medical conditions may experience other, more serious risks.
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Before starting medication, potential complications should be discussed with your doctor.
Fox News Digital has reached out to Bristol-Myers Squibb and the Schizophrenia and Psychosis Action Alliance for comment.
