FDA Approves Cobenfy: First Novel Schizophrenia Drug in Decades

The Food and Drug Administration (FDA) has approved Cobenfy, marking the first novel antipsychotic treatment for schizophrenia in decades. This innovative drug offers a new approach to managing the condition, aiming to reduce disabling side effects, particularly weight gain, which is common with existing antipsychotic treatments.

Traditionally, antipsychotics have operated by blocking dopamine receptors to mitigate symptoms like hallucinations and paranoia. While effective for many patients, these medications often come with serious drawbacks, including significant weight gain that contributes to a heightened risk of cardiac disease and early mortality. Many patients discontinue their use due to feelings of sluggishness and lack of motivation.

Cobenfy takes a different route by indirectly influencing dopamine levels through adjustments in another neurotransmitter, acetylcholine. Researchers hope this novel mechanism will help address stubborn symptoms, such as lack of motivation and anhedonia (the inability to feel pleasure).

“This is the first significant advancement in medication mechanisms for schizophrenia in many years, generating considerable excitement for its potential,” said Dr. Frederick C. Nucifora from Johns Hopkins School of Medicine.

However, some experts express caution regarding the drug’s long-term efficacy and safety. Current research comprises only three short-term controlled studies, each lasting five weeks, leaving questions about the drug’s effectiveness over more extended periods and the potential for long-term neurological side effects.

Dr. David Rind, medical director of the Institute for Clinical and Economic Review, noted, “We don’t yet understand how Cobenfy works beyond five weeks, making both patients and doctors hesitant to fully embrace the claims.”

Bristol Myers Squibb (BMS), the drug’s marketer, has shared summaries indicating that patients taking Cobenfy for a year did not experience the metabolic changes or movement disorders often seen with traditional antipsychotics. Comprehensive results are expected later this year.

The drug has attracted interest from investors, with projections suggesting it could generate between $3 billion and $5 billion annually, especially if positive outcomes are found in studies examining its use for psychosis related to dementia.

BMS has set the wholesale price for Cobenfy at $1,850 per month, roughly $22,500 annually, consistent with other branded antipsychotics. The company positions the drug as a “switch opportunity” for patients who have experienced adverse effects from multiple antipsychotic treatments—around 80% of schizophrenia patients fall into this category.

Unlike existing antipsychotics, Cobenfy will not carry the FDA’s boxed warning for serious adverse reactions. However, it is contraindicated for patients with liver impairment and can potentially cause liver damage.

Patty Mulcahy, a filmmaker diagnosed with schizophrenia, expressed enthusiasm for Cobenfy, sharing her struggles with current medications that control symptoms at the expense of her quality of life. “I just want to wake up feeling energized and excited for the day,” she said.

While psychotic disorders like schizophrenia affect a small percentage of the adult population, the impact is profound. Many individuals with schizophrenia face challenges accessing comprehensive care, leading to cycles of homelessness and incarceration.

Dr. Nucifora noted that existing treatments largely address only one cluster of symptoms, leaving many patients struggling with debilitating experiences. “It can be very frustrating to find effective treatments,” he remarked.

Cobenfy’s development stemmed from previous research into xanomeline, originally intended as a dementia treatment but shelved due to gastrointestinal side effects. Karuna Therapeutics acquired the license for xanomeline in 2012 and worked to mitigate its side effects, ultimately leading to the creation of Cobenfy.

In clinical trials, Cobenfy showed significant improvement in symptom management compared to placebo over five weeks, though about 20% of participants reported gastrointestinal issues.

As excitement builds around this new treatment, experts stress the importance of continued research and monitoring to fully understand Cobenfy’s long-term effects.