There is a new drug that promises to have fewer side effects
What is a drug for schizophrenia? A case study of the Cobenfy-based placebo-controlled analogue of a neuromodulator
She told them to keep trying. It’s really hard to go on and off medications when you can’t find the right one, but when you do find the right one, it makes a huge difference.
“Every time I have an episode, I lose bits of myself and bits of functionality … and that’s not fair to my husband, and I hate it,” she says. It would be wonderful if I had something that would help me with my initiative.
As for Tiffany, she’s interested in trying the drug down the road. Although previous drugs only addressed the positive symptoms of schizophrenia, Cobenfy has shown to decrease the negative symptoms, such as apathy and lack of motivation.
The FDA based its approval on 5-week double-blind, placebo-controlled studies. The patients and the clinicians didn’t know which one was which until the study was over. The short study length has prompted some experts to point out that questions remain about the drug’s long-term safety and efficacy.
He admits that he has a lot of patients and their parents who are excited about a new treatment option. 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.
Miller and his team decided to add a second medicine that already works for the bladder problem to shut down the GID. The trick: That medication can’t cross into the brain from the blood.
How Easy is It to Get Insurance for Schizophrenic Patients? Dr. Jacob Ballon on Dopamine Hypothesis and the “Meds Game”
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 is not clear how easy it will be for patients to get insurance.
According to Dr. Jacob Ballon, insurance will typically require people to use at least two generic drugs before they pay for it.
Dopamine is the neurotransmitter usually associated with reward and learning, but it actually has a lot of functions. One drug had a part in controlling Tiffany’s movement.
The dopamine hypothesis proposed that scurvy is associated with too much dopamine activity.
Since the first antipsychotic drug was introduced in the 1950s, the subsequent medications to treat psychosis act on the same chemical that helps the brain communicate with the rest of the body: dopamine.
Then, she played what she calls the “meds game,” trying different pills until one worked for her. Some of the side effects were brutal. Seroquel drugs can increase the risk of diabetes and cause weight gain.
KarXT: A New Antipsychotic Drug that Could Help Patients with Schizophrenic Attitudes and Disturbed Affect
“I was opening presents — everyone was happy. I’m sitting and there’s nothing going on. She says 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 wasn’t familiar with herself when she watched a video of her birthday party.
Tiffany is a librarian in Oklahoma and she noticed the difference. She asked us to use only her first name because of the stigma associated with schizophrenia.
The pill will be marketed as Cobenfy, but it was referred to during development as KarXT. It seems to have fewer side effects than current medicines.
There were also strong signs of cognitive benefit, with preliminary indications5 that KarXT might also help to mitigate symptoms such as blunted affect and lack of motivation. “It’s encouraging,” Stephen Marder, a psychiatrist at the University of California, Los Angeles, says of these ancillary effects. (Marder assisted with some of the analyses). But these effects need to be verified in a “focused study,” he says.
This progress is leading clinicians to imagine a day when schizophrenia treatment might be more tailored to individual needs and therefore more useful for the many people who don’t benefit from current therapies or abandon them because of intolerable side effects.
“This is an option that we do not have right now,” says Ann Shinn, a psychiatrist with no commercial ties to KarXT.
Karuna Therapeutics: Exploring new pharmacology and biology for schizophrenia treatment with the combined treatment of xanomeline and trospium
Trials showed that the drug offered both antipsychotic and cognitive benefits1,2. But xanomeline also caused nausea, vomiting and stomach pain — because muscarinic receptors are active in the gut as well as the brain — leading Lilly to ultimately shelve the drug.
In 2009, Miller formed a company called Karuna Therapeutics, based in Boston, Massachusetts. Karuna combined xanomeline with a drug called trospium. This well-understood molecule blocks muscarinic receptors and does not cross the blood–brain barrier, meaning that it selectively prevents side effects in the gut without interfering with xanomeline’s action in the brain.
The drug has a few shortcomings. It requires twice-daily administration, and studies show that people with schizophrenia who receive more frequent dosing schedules are more likely to stop taking their treatment. Many antipsychotics can be used long-term as long-acting injections, which means they only need a few annual doses, and that is a big limitation.
KarXT also comes with an anticipated price tag of roughly US$20,000 per year7, raising concerns among health economists about its cost-effectiveness compared with alternatives. Despite this, most industry analysts predict strong demand, with peak annual sales projected in the billions. This potential drove Bristol Myers Squibb (BMS) in Princeton, New Jersey, to acquire Karuna for approximately $14 billion this year.
Steven Paul, the ex-chief executive of Karuna, is looking forward to learning how to find new ways to harness the therapeutic strategy that KarXT has helped to unleash.
“Now we have new biology and new pharmacology to explore,” he says. “It will be fun and scientifically relevant — and, hopefully, clinically beneficial to patients — to find out.”
The medication is the first in decades to have a different mode of action than the drugs used today, which results in better symptom relief and fewer side effects.
Bristol-Myers Squibb has approved its drug Cobenfy for the treatment of schizophrenia. It aims to reduce the negative symptoms like apathy and lack of motivation. It will be available from October at $1,850 a month, according to the company. Cobenfy is a monoclonal antibody that binds to muscarinic receptors, a group of receptors found in the gut and the brain.