The Food and Drug Administration has approved a new type of treatment for schizophrenia in adults: Cobenfi, a twice-daily drug. Steve Berkowitz/Bristol-Myers Squibb Hide Caption
Toggle caption Steve Berkowitz/Bristol-Myers Squibb
For the first time in decades, the Food and Drug Administration has approved a new type of schizophrenia drug.
The twice-daily pill sold by Bristol-Myers Squibb is called Cobenfy, but during development it was called KarXT. Its main advantage is that it has fewer side effects than current drugs.
That difference has caught the attention of patients like Tiffany, a librarian in Oklahoma. She asked that we only use her first name because of the stigma associated with schizophrenia.
When she was first given antipsychotic medication, she says she felt like a zombie. Watching a video of her birthday party that year, she didn’t recognize herself.
“I was opening presents and everyone was happy. And I’m just sitting there and nothing’s happening. I’m kind of staring at a blank wall,” she said. says. “So I lied and told everyone I was better.”
So she stopped taking the medication and basically remained on it for years until she experienced another psychotic episode.
She then played what she called the “drug game”, trying different drugs until she found one that worked. However, some of the side effects were severe. Common antipsychotic drugs can cause weight gain and increase the risk of diabetes.
One of them left Tiffany with motor problems.
“So I paced my office eight hours a day, exactly three-and-a-half steps, turn, three-and-a-half steps, turn,” she says. “It was a nightmare.”
Decades of dopamine-focused drugs
Since the introduction of the first antipsychotic drugs in the 1950s, subsequent psychosis medications act on the same chemical, dopamine, that helps the brain communicate with the rest of the body.
“The dopamine hypothesis suggests that schizophrenia is associated with excessive dopamine neurotransmission, or excessive dopamine activity,” says a clinical researcher in schizophrenia and bipolar disorder at McLean Hospital near Boston. Dr. Ann Shin, a psychiatrist who directs the program, says:
Dopamine is a neurotransmitter typically associated with reward and learning, but it actually has many functions. For example, it also plays a role in controlling movement. That’s why the drug sped up Tiffany’s pace.
New drugs target different brain receptors
Cobenfi is the first new psychotic drug that does not affect dopamine.
“I got really interested in schizophrenia and through that research I became really interested in the idea of targeting muscarinic receptors, because there were some fortuitous clinical findings that suggested potential efficacy. “This is very difficult in psychiatry,” says the drug’s lead inventor. Andrew Miller.
He’s talking about a 1997 study in Alzheimer’s patients whose release was delayed despite its effectiveness in reducing psychosis.
Muscarinic receptors get their name from their response to muscarine, a chemical found in some mushrooms. The problem with developing drugs that activate them in the brain is that they can trigger receptors in the gastrointestinal tract. The patients couldn’t stand it.
So Miller and his team decided to add a second drug, already used for overactive bladder, to block receptors in the gastrointestinal tract. The secret: the drug cannot enter the brain from the blood.
That is, the muscarinic receptors in the body are stopped, but the original drug is not stopped from doing its job in the brain.
“Basically, Karuna did a great job of putting everything together into a compound,” Singh says.
She’s talking about Miller’s company, Karuna Therapeutics, which was acquired by pharmaceutical giant Bristol-Myers Squibb for $14 billion earlier this year.
How much does it cost?
Bristol-Myers Squibb said the drug will go on sale starting in October for $1,850 a month, putting it in line with other schizophrenia drugs. It’s unclear how easy it will be for patients to get insurance coverage for Cobenfi.
“As with many new drugs, insurance generally requires that you try at least two generic drugs first before paying for them,” said Dr. Jacob Baron, associate professor of psychiatry at Stanford University. “It will become.” .
Still, he says, many patients and their parents are excited about the possibility of new treatments. Baron is involved in ongoing research into how Cobenfi fits in with existing drugs and whether it can be used in combination.
The new drug may not be suitable for everyone, but it could help patients who have difficulty with existing treatments.
The FDA based its approval on a 5-week, double-blind, placebo-controlled study. This meant that some patients received Cobenfi and others received a placebo, but neither the patients nor the clinicians knew which one until the end of the study. Because of the short study period, some experts say questions remain about the drug’s long-term safety and effectiveness.
Common side effects of Cobenfy include nausea, constipation, and increased heart rate.
As for Tiffany, she’s interested in trying the drug in the future. Unlike previous drugs that only addressed the so-called positive symptoms of schizophrenia, such as hallucinations and delusions, Cobenfi has been shown to reduce “negative” symptoms such as apathy and lack of motivation.
“Every time I have a seizure, I lose a part of myself and a part of my function…and it’s unfair to my husband and I hate it,” she says. “So if there’s something that helps us take a little more control, that’s great.”
She also offers advice to people with schizophrenia who are looking for appropriate treatment.
“Just keep trying,” she says. “It can be really difficult to stay on and off medications, but finding the right medication can make a huge difference day and night.”
