The FDA approves a new drug for schizophrenia

The first new drug in decades to combat schizophrenia was approved by the U.S. Food and Drug Administration on Thursday. Medicines Agency.

Cobenfy (xanomeline/trospium chloride) could bring patients what they have long hoped for: a means to relieve the hallucinations and “voices” that disrupt their lives, without the weight gain and sluggishness of current dopamine-focused medications.

Cobenfy does affect dopamine, but indirectly via so-called cholinergic receptors, which changes the activity of another neurotransmitter, acetylcholine.

“Schizophrenia is a leading cause of disability worldwide. “It is a serious, chronic mental illness that often affects a person’s quality of life,” said Dr. Tiffany Farchione, director of psychiatry in the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research.

“This drug represents the first new approach to treating schizophrenia in decades,” she said in an agency news release. “This approval offers a new alternative to the antipsychotics previously prescribed to people with schizophrenia.”

According to the FDA, about 1% of people suffer from schizophrenia, which is characterized by intrusive thoughts, hallucinations (including voices), and paranoia that can severely interfere with daily life and social interactions with others.

It can be a debilitating disease and significantly increase the chances of dying at a young age, the agency said. Nearly 5% of people with schizophrenia die by suicide, the FDA found.

Almost all existing medications for schizophrenia have helped control symptoms by blocking dopamine receptors in brain cells.

This can make symptoms manageable, but people taking medication have complained of weight gain, lack of motivation and sluggishness as side effects for decades, and discontinuation of medication is common.

Cobenfy is manufactured by Bristol Myers Squibb. The drug was tested in two five-week studies that were “double-blinded”: neither the patients nor those selling the drugs knew whether the patient was receiving Cobenfy or a placebo.

Patient outcomes were assessed using a standard 30-point scale measuring schizophrenia symptoms.

“In both studies, participants who received Cobenfy experienced a significant reduction in symptoms from baseline to week five,” the FDA said.

Side effects – particularly gastrointestinal side effects such as nausea, indigestion, constipation and vomiting – may occur. You could also experience an increase in heart rate and acid reflux.

Due to the risk of liver damage, Cobenfy is not recommended for use in people whose liver is already damaged.

Unlike other antipsychotics used to treat schizophrenia, Cobenfy “has no warnings and precautions for the class of atypical antipsychotics [FDA-mandated] Bristol Myers Squibb points out in a company press release that there is no boxed warning on the label.

The two studies only lasted five weeks, so longer-term effectiveness and safety remain unclear.

“We don’t know how it’s essentially working over the last five weeks,” Dr. David Rind, medical director of the Institute for Clinical and Economic Review, which tracks newly approved drugs.

People “are a little wary of claims before they actually see what's happening with the drugs,” Rind said The New York Times. He wondered whether Cobenfy might have longer-term effectiveness or neurological effects such as motor disorders.

According to the JustBristol Myers Squibb said it had conducted individual case studies of people who took Cobenfy for a year and which showed they did not develop metabolic changes or signs of a movement disorder. The company said it plans to report these results later in 2024.

Cobenfy won't be cheap: Bristol Myers Squibb said the drug will cost $1,850 a month, or around $22,500 a year Just reported.

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