A new drug has been approved for treatment of schizophrenia In adults.
On Thursday, the U.S. Food and Drug Administration (FDA) approved COBENFY (xenomelin and trospium chloride), an oral drug manufactured by Bristol Myers Squibb in New Jersey.
This is the first new symbol class of drugs for a brain disorder over several decades, according to a press release.
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The company reported that COBENFY is expected to be available in the US in late October.
A new drug has been approved to treat schizophrenia in adults. (iStock)
“Today’s landmark 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 – one that is poised to change the treatment paradigm. Chris Boerner, Ph.D., chairman of the board and chief executive officer of Bristol Myers Squibb, said in the press release.
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Schizophrenia is a serious mental illness that affects a person’s thoughts, feelings, and behavior.
This often causes hallucination, illusionDisorganized speech and loss of contact with reality, the Mayo Clinic explains on its website.
COBENFY (xenomelin and trospium chloride) is an oral medication manufactured by Bristol Myers Squibb in New Jersey. (Bristol Myers Squibb)
This disorder can also cause lack of emotional expression, lack of motivation, cognitive dysfunction, and social isolation.
About 2.8 million people in the US and 24 million globally suffer from schizophrenia.
This disorder has been traditionally treated antipsychotic drugsBut studies have shown that about 40% of patients do not respond to treatment and 60% experience “insufficient improvement” in symptoms or “intolerable side effects.”
COBENFY is expected to be available in the US in late October, the company said. (Bristol Myers Squibb)
COBENFY works differently than currently available schizophrenia medicines.
“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 Kakkar, MD, chief scientific officer and medical director of SEGAL Trials. ” and drug inventors clinical trialsIn the release.
“Schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of on and off treatments.”
“The approval of Cobenfi is a transformative moment in the treatment of schizophrenia because, historically, drugs approved to treat schizophrenia have relied on the same primary pathways in the brain.”
“By leveraging an innovative pathway, COBENFY offers a new option to manage this challenging condition.”
“Today’s historic approval of our first-in-class treatment for schizophrenia is an important milestone for the community,” said Chris Boerner, PhD, Chairman of the Board and Chief Executive Officer of Bristol Myers Squibb. (iStock)
Sam Clark, founder and CEO of 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 approved (COBENFY) for the treatment of patients with schizophrenia, which is a huge leap forward in this field. psychiatric place,” He said.
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Clark added, “These patients are living with a difficult disease, and this drug with a new mechanism of action is sure to have a significant impact.”
“We look forward to continuing the breakthrough as this approval paves the way for future breakthroughs and novel patient-centered therapeutics.”
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The approval follows three phases of clinical trials that showed “statistically significant improvement in disease” as a result of COBENFY.
Schizophrenia is a serious mental illness that affects a person’s thoughts, feelings, and behavior and often causes hallucinations and delusions. (iStock)
In terms of safety, the most common side effects of the drug during clinical trials were nausea, dyspepsia, vomiting, diarrhea, constipation, hypertension, abdominal pain. accelerated heart rateDizziness and gastroesophageal reflux disease, the release said.
Patients with certain existing medical conditions may experience other, more serious risks.
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People should discuss possible complications with a doctor before starting the medication.
Fox News Digital contacted Bristol Myers Squibb and the Schizophrenia and Psychosis Action Alliance requesting comment.
