The US approves a new drug for the treatment of schizophrenia

“It’s hard to sleep, but it’s worth it,” says Tiffany Ballon, CEO of Cobenfy, a drug for schizophrenia

She says to keep trying. “It’s really hard to go on and off medications, but when you find the right one, it makes a huge difference — night and day.”

She says she doesn’t like having an episode where she loses bits of herself and her husband. I would like to have something that would make me have more initiative.

Tiffany is interested in trying the drug down the road. The drug Cobenfy has been shown to reduce the “negative” symptoms of the disease like apathy and lack of motivation, unlike previous drugs which only tackled the so-called positive symptoms.

The FDA approved studies that were double-blind and placebo controlled. The patients and the clinicians were not aware which one of them got a placebo or Cobenfy. The short study length has prompted some experts to point out that questions remain about the drug’s long-term safety and efficacy.

Still, he has a lot of patients — and their parents — who are excited about a potential new treatment option, he says. Ballon is working on an ongoing study of how Cobenfy fits in with existing drugs and whether they can be used together.

“I became really interested in schizophrenia and through that work became really interested in the idea of targeting muscarinic receptors because here was a serendipitous clinical finding that suggested potential efficacy, which is really hard to come by in psychiatry,” says the drug’s lead inventor, Andrew Miller.

So Miller and his team decided to add a second medicine — one already used for overactive bladder — to shut down the gastrointestinal receptors. It can’t cross into the brain from the blood.

Karuna Therapeutics: A Drug for Schizophrenic Cobenfy, the Brain-Body Interaction, and What Patients Really Learn About Dopamine

She’s talking about Miller’s company, Karuna Therapeutics, which was acquired by pharmaceutical heavyweight Bristol Myers Squibb for $14 billion dollars earlier this year.

Bristol Myers Squibb says the drug will be available starting in October at $1,850 a month, which is in line with other schizophrenia treatments. It’s unclear how easy it will be for patients to get insurance coverage for Cobenfy.

“If it’s like a lot of the other new medications, insurance is generally going to mandate that people try at least two generic medicines first … before they will pay for it,” says Dr. Jacob Ballon, an associate professor of psychiatry at Stanford University.

Dopamine is the neurotransmitter usually associated with reward and learning, but it actually has a lot of functions. It also plays a role in controlling movement, for example — that’s why that one drug made Tiffany pace.

The dopamine hypothesis proposed that schizophrenia was associated with excessive dopamine activity, according to Dr. Ann Shinn, a clinical psychologist at a hospital in Boston.

The first drugs for treating psychosis act on the same chemical as dopamine, which helps the brain communicate with the rest of the body.

Then, she played what she calls the “meds game,” trying different pills until one worked for her. Some of the side effects were brutal. Common antipsychotic drugs can cause weight gain and increase the risk for diabetes.

An Unknown Person’s First Name and the Future of the Treatment of Schizophrenic Disorder: The Cobenfy Antipsychotic Drug

Everyone was happy when I opened presents. And I’m just sitting there like, there’s nothing going on. She says that she’s staring at a blank wall. “And so I lied and I told everyone I was better.”

When she was first put on an antipsychotic drug, she says it made her feel like a zombie. She didn’t recognize herself when she watched a video of her birthday party.

Tiffany, a librarian in Oklahoma, considers that difference to be significant. She asked us to use only her first name because of the stigma associated with schizophrenia.

The twice-a-day pill to be marketed by Bristol Myers Squibb will be called Cobenfy, though it had been referred to as KarXT during development. It seems to have fewer side effects than current medicines.

Many of the next-generation drug candidates will be designed to engage muscarinicreceptors in the brain. Several follow-on schizophrenia therapies are already in or nearing clinical trials, showing promise for improved tolerability and more convenient dosing schedules.

According to a doctor at the Zucker School of Medicine in New York, this will be a revolution of the treatment of psychosis. “Now we will now be able to treat people who haven’t been helped with traditional antipsychotics. That is very exciting.

Ann Shinn is a psychiatrist at a hospital inMassachusetts who doesn’t have a commercial relationship with KarXT.

Karuna: A New Medicine to Optimize the Effect of Muscarinic Signalling on Psychiatric Patients with Schizophrenia

Trials showed that the drug offered both antipsychotic and cognitive benefits1,2. Lilly ended up abandoning xanomeline, because it made you nausea, vomiting and stomach pain, due to the muscarinic receptors in the gut and brain.

Miller started a company called Karuna the same year. xanomeline and trospium were combined by Karuna. It is known that the molecule blocks muscarinic receptors and does not cross the brain barrier, meaning that it can prevent side effects without interfering with xanomeline in the brain.

The drug has a few problems. It requires twice daily administration, and is associated with higher rates of non-adherence and discontinuation of treatment in people with schizophrenia. “That’s a big limitation,” says Nate Sutera, a psychiatric pharmacist at the University of Nebraska Medical Center in Omaha — particularly because many antipsychotics are now available as long-acting injectables, requiring only a few doses annually.

The price tag for KarXT, which is expected to be $200,000 per year, has health economists worried about its cost-effectiveness. Most industry analysts predict that peak annual sales will be in the billions. This is what drove BristolMyers Squibb to buy Karuna for more than $13 billion this year.

Steven Paul, the former head of Karuna and now a professor of Psychiatry at the Washington University school of medicine, is looking to discover the best ways to use muscarinic signalling as a therapeutic strategy.

He says that there’s new biology and new pharmacology to explore. “It will be fun and scientifically relevant — and, hopefully, clinically beneficial to patients — to find out.”

The medication is novel in that it has a different mode of action that allows it to give better symptom relief with less side effects.