FDA Approves First New Schizophrenia Drug in Decades

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) on Thursday approved the first new treatment for adults with schizophrenia in over three decades.

The xanomeline and trospium chloride capsules for oral use will be marketed under the brand name Cobenfy.

The FDA said that it approved Cobenfy after clinical trials of the drug demonstrated reductions in schizophrenia symptoms among participants.

Produced by Bristol Myers Squibb, Cobenfy is the first oral medication for treating schizophrenia by targeting the brain’s cholinergic receptors rather than dopamine receptors, which have traditionally been the standard treatment approach, according to the FDA’s Sept. 26 statement.

“This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed,” Tiffany Farchione, director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The first antipsychotic drugs for schizophrenia were discovered in the 1960s and 1990s, including chlorpromazine and haloperidol, which are sold under the brand names Thorazine and Haldol, respectively.

Schizophrenia is a mental illness that affects how a person thinks, feels, and behaves. The condition can cause hallucinations, such as hearing voices, and difficulties in controlling thoughts and trusting others.

“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” Farchione said.

Bristol Myers said it expects Cobenfy to be available in late October, adding that it planned to launch a program aimed at supporting patients who have been prescribed Cobenfy when the product is released.

“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,” Bristol Myers CEO Chris Boerner said in a statement.

In April, Bristol Myers released results of clinical trials evaluating “the long-term efficacy, safety, and tolerability” of its new drug, which was called KarXT at the time, in adults with schizophrenia.

The study indicated that more than 75 percent of patients saw a 30 percent improvement in their symptoms. The drug also had “a favorable impact” on weight and long-term metabolic profiles. The company stated that a total of 110 patients took part in the interim efficacy analysis.

“The consistency of efficacy results across all EMERGENT clinical trial programs is encouraging and suggest KarXT could provide a differentiated treatment approach for people living with schizophrenia,” Elan Cohen, principal investigator at CenExel Hassman Research Institute and investigator in the clinical program, said in an Apr. 6 statement.

Prescribing Cobenfy

The FDA has advised against prescribing Cobenfy to patients with urinary retention, kidney or liver disease, gastric retention, untreated narrow-angle glaucoma, or a history of hypersensitivity to Cobenfy or its components.

The labeling information of the new drug includes warnings of potential urinary retention, increased heart rate, decreased gastric movement, or swelling of the lower layer of skin, the FDA stated.

“Cobenfy is substantially excreted by the kidney and is not recommended in patients with moderate to severe renal impairment,” the agency stated.

Cobenfy’s common side effects include nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness and gastroesophageal reflux disease, according to the FDA.

Bristol Myers obtained the drug Cobenfy, or KarXT, through its $14 billion takeover of Karuna Therapeutics in December last year.

Reuters contributed to this report.