by Jennifer Porter Gore
It’s a frustration for both doctors who treat patients with schizophrenia and for people living with it: the most effective antipsychotic drugs have side effects, so unpleasant patients would rather live with terrible symptoms — including hallucinations and paranoia — than take them.
In a promising breakthrough, however, the Food and Drug Administration has approved the first new drug in decades to treat chronic schizophrenia. The drug, they say, is effective and has fewer drastic or debilitating side effects like extreme drowsiness, weight gain, and restlessness.
The new drug could be highly beneficial to the Black community, where the rate of schizophrenia diagnoses is estimated to be up to five times higher than in the white community.
A Life-Altering Illness
“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,” said Dr. Tiffany Farchione, director of the psychiatry and neuroscience division of the Food and Drug Administration’s Center for Drug Evaluation and Research.
A New Approach to Treatment
“This drug takes the first new approach to schizophrenia treatment in decades,” she says. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Dr. Hannah Brown, a psychiatry professor at Boston University’s Chobanian and Avedisian School of Medicine, said the new drug’s promise of improved “tolerability” could help break a maddeningly persistent cycle of treatment and relapse.
“People have symptom relapses because they stop taking the medications, and they often stop taking them because the side effects are really terrible,” Brown said in an interview with AARP.
What Is Schizophrenia?
Schizophrenia is a brain disorder that is closely linked to psychosis and disrupts a person’s ability to remain connected to reality. Symptoms of the disease can include aural and visual hallucinations, severe delusions, and extreme paranoia.
Schizophrenia affects approximately 24 million people worldwide, according to the World Health Organization. Approximately 1% of Americans are affected by schizophrenia, which, in most cases, first appears in men during their late teens or early 20s and in women during their 20s or early 30s.
Black Americans, however, are estimated to be three to five times more likely to be diagnosed with schizophrenia than whites. Experts attribute the disparity to a variety of issues, from possible implicit bias by medical providers to higher rates of traumatizing stressors due to racism.
How Does Cobenfy Work?
The newly approved drug, Cobenfy, addresses symptoms by affecting the brain differently than its predecessors.
While effective and popular among doctors, the older medications previously had uncomfortable, disruptive side effects such as weight gain, pacing, and drowsiness. Those side effects are persistent, which often causes schizophrenia patients to stop taking their medicine.
By contrast, the most common Cobenfy side effects in clinical trials were somewhat mild by comparison: nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, increased heartbeat, dizziness, and acid reflux, according to the FDA.
While many psychiatrists are encouraged that this new drug is on the market, others are cautiously optimistic, noting that the drug is in its early stages.
Cautious Optimism and a High Cost
“The new drug is promising,” says Dr. Vinod Srihari, a psychiatrist at the Yale University School of Medicine. “But we need to keep in mind that these were five-week studies of a drug to treat an illness that is lifelong, and further studies need to be done to evaluate longer-term impact and side effects.”
Then there’s the cost: According to its manufacturer, Bristol Myers Squibb, Cobenfy has a sticker price of $1,850 a month. Insurance coverage will depend on a patient’s carrier.
Still, it’s possible that Medicaid will cover the drug with no out-of-pocket costs for members who qualify. People on Medicare Part D or Medicare Advantage Part C should check their health insurance pharmacy coverage for more information.