The Food and Drug Administration approved Cobenfy, a treatment for schizophrenia. This is the first time in decades that a new class of antipsychotic drugs has emerged. Until now, most available treatments have relied on targeting dopamine receptors in the brain, but Cobenfy takes a different approach.
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Cobenfy is the first FDA-approved antipsychotic medication that targets cholinergic receptors instead of dopamine receptors.
Most existing treatments for schizophrenia rely on dopamine receptor antagonism to control symptoms, which can lead to various side effects such as weight gain, sluggishness and lack of motivation.
Cobenfy affects dopamine indirectly by modulating acetylcholine, a neurotransmitter associated with various cognitive functions through cholinergic receptors. This new approach offers hope to patients who struggle with the debilitating side effects of current antipsychotic medications.
Schizophrenia is a mental illness affecting about 1% of Americans and is one of the leading causes of disability worldwide. Individuals with schizophrenia often experience hallucinations, delusions, disorganized thinking and difficulty in social interactions and motivation.
Cognitive impairments and social withdrawal are also common. The illness has an impact on life expectancy with almost 5% of patients dying by suicide.
Cobenfy’s effectiveness was demonstrated in two pivotal, 5-week, double-blind, placebo-controlled clinical trials involving adults diagnosed with schizophrenia. The primary efficacy measure was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to the 5th week.
The PANSS scale is a standard 30-item measure of schizophrenia symptoms, rated by clinicians on a seven-point scale.
In both trials, patients who received Cobenfy showed a meaningful reduction in symptoms compared to those receiving a placebo.
This reduction was seen across the board, an improvement in controlling both positive symptoms such as hallucinations and delusions and negative symptoms such as social withdrawal and lack of motivation.
Although Cobenfy provides a promising alternative for schizophrenia treatment, it is not without side effects. Commonly reported side effects include nausea, indigestion, constipation, vomiting, hypertension (high blood pressure), abdominal pain, diarrhea, increased heart rate (tachycardia), dizziness and gastroesophageal reflux disease (GERD).
The drug also comes with warnings regarding more severe side effects such as urinary retention, angioedema, increased heart rate and decreased gastric movement.
Liver damage is a concern with Cobenfy and it is not recommended for patients with liver impairment. The drug should be discontinued if patients experience symptoms of liver damage such as yellowing of the skin or eyes, dark urine and unexplained itching.
Patients with urinary retention, moderate to severe kidney or liver disease, untreated narrow-angle glaucoma, gastric retention or those with a history of hypersensitivity to Cobenfy or its components should not take the drug.
Cobenfy’s approval is based on three controlled studies each lasting five weeks. These studies demonstrated a huge reduction in schizophrenia symptoms measured through a standard scale of psychotic symptoms such as hallucinations and hostility.
Patients on Cobenfy saw their symptom scores improve by an average of 20 points compared to a 10-point improvement for those on a placebo.
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Experts have pointed out that there is still a lack of long-term data on the efficacy and safety of Cobenfy. The studies were short-term and there’s uncertainty about whether the drug will have long-term neurological side effects or whether it will be effective over time.
During clinical trials, about 20% of patients reported gastrointestinal side effects including nausea, constipation, vomiting and stomach pain. These side effects are generally considered mild to moderate and for many patients, they dissipated over time.
The FDA has issued a warning that Cobenfy should not be administered to patients with liver impairment, as it could cause liver damage.
One of the benefits of Cobenfy, as reported by Bristol Myers Squibb is that patients did not experience movement disorders or metabolic changes including weight gain, after taking the drug for one year.
Bristol Myers Squibb (BMS) has set Cobenfy’s wholesale price at $1,850 per month or $22,500 annually. While this is on par with other branded antipsychotic medications concerns about cost and access remain, especially for patients who are uninsured or underinsured.
BMS expects most patients especially those covered by Medicare and Medicaid to have minimal out-of-pocket expenses. Currently around 80% of patients with schizophrenia in the US are covered by government insurance.
BMS plans to launch a program to help patients afford Cobenfy, although the extent of this assistance is yet to be clarified.
Wall Street has shown excitement for Cobenfy projecting it to generate between $3 billion and $5 billion annually.
Analysts believe this new class of drugs could revolutionize the treatment of not only schizophrenia but also other disorders like bipolar disorder, Alzheimer’s psychosis and autism-related irritability.
Cobenfy was developed by Karuna Therapeutics, which BMS acquired last year for $14 billion. This acquisition is viewed as a strategic move by BMS to offset the revenue loss expected from expiring patents on some of its top-selling treatments.
BMS is not stopping with schizophrenia. The company is actively studying Cobenfy for other conditions including psychosis related to Alzheimer’s disease, bipolar mania and autism-related irritability. Data from studies on Alzheimer’s-related psychosis is expected in 2026.
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