Why approval of KarXT, the first new drug for schizophrenia in decades, is a big deal

The US Food and Drug Administration has approved a new drug for schizophrenia.

The drug, known as KarXT or Cobenfy, belongs to Bristol Myers Squibb.

Bristol Myers got the drug via its $14 billion takeover of Karuna Therapeutics last year.

The first new type of antipsychotic medicine in decades, it offers new hope for those afflicted by the disease.

But why is this such a big deal?

Let’s take a closer look:

A brief look at schizophrenia

First, let’s briefly examine schizophrenia.

Schizophrenia is a chronic brain disorder.

It causes persistent delusions and hallucinations and significantly impairs the way patients perceive reality.

It impacts under 1 per cent of the US population.

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Around 3.7 million people in the US have a history of schizophrenia, research shows.

Disorganised speech, trouble with thinking and lack of motivation are also some of the other symptoms.

Though the disease has no cure, treatment is available.

Antipsychotic medications can reduce symptoms of the illness and precent future episodes.

Sarah Hamilton, MD, a psychiatrist at the Early Psychosis Intervention Center at The Ohio State University Wexner Medical Center in Columbus, Ohio, told Healthcentral.com, “Antipsychotics help treat schizophrenia by eliminating or reducing psychotic symptoms.”

“They primarily address the positive symptoms of the illness, and lessening these symptoms can lead to better quality of life, though many individuals will continue to suffer from the negative symptoms of schizophrenia such as lack of motivation, affective flattening, and speech difficulties as well as impaired cognition.”

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Other medications can also end up getting the patient addicted. This is a problem because the data show that schizophrenia patients are more vulnerable to substance abuse than the general population.

How Cobeny is different

Because antipsychotics usually work by blocking the brain’s dopamine receptors.

The first antipsychotic, antipsychotic, developed in 1951, worked exactly this way.

“These medications extensively block dopamine receptors throughout the brain and reduce the positive symptoms of schizophrenia," Hamilton added.

However, these medications usually come with side effects such as weight gain and movement disorders.

“However, due to this blockade, these medications have a higher tendency to negatively impact physical coordination, balance, and other motor skills like walking,” Hamilton added.

But Cobenfy is different.

While it too targets dopamine levels in the brain, it does this by tackling the levels of acetylcholine.

Cobenfy also does not include a warning about the risk of increased mortality in some elderly patients, unlike other commonly used drugs for the disorder.

It also comes without common side effects, such as weight gain and movement disorders, found in other drugs.

William Blair analysts expect $2.5 billion in US sales for Cobenfy by 2030.

Bristol said it expects to make the drug available to patients by late October at a list price of $1,850 a month or about $22,500 annually.

FDA’s approval was based on data from two studies in which patients on the drug experienced a meaningful reduction in symptoms.

The New York Times quoted Karuna as saying that its study examined 252 people with schizophrenia.

Of these, half were prescribed Cobenfy and the others given a placebo.

They were told to list their symptoms including hallucinations, hostility, tension and disorientation.

Those on Cobenfy saw symptoms diminish 20 points compared to 10 points in the placebo group.

The newspaper quoted the company as saying that the full study would be published later this year.

What do experts say?

Experts are excited.

Jelena Kunovac, a clinical assistant professor at University of Nevada, Las Vegas, told USA Today, “The field is ready to try something different. This medication may be a game changer for some subset of patients.”

Dr Frederick C Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, told The New York Times, “This is the first time, really since the advent of these medicines, that a new mechanism has come out, so there is really a lot of excitement that maybe we have something new to treat patients with.”

“…there is an unmet need still in the treatment of schizophrenia, particularly in patients who may show response to the positive symptoms but still have residual negative symptoms,” said Alan Schatzberg, psychiatry professor at Stanford University School of Medicine.

Schatzberg added that drug could be a “game changer” for schizophrenia patients.

But questions about how the drug will do in the long-term also remain.

Dr David Rind, the medical director of the Institute for Clinical and Economic Review, pointed out that all three studies on the drug thus far limit its use to five weeks.

“We don’t know how it works in any substantial way past five weeks,” Rind told The New York Times. Patients and doctors, he added, “are a little wary of claims before they actually see what happens with the drugs.”

There are also other concerns.

As per Nature.com, patients must take Cobenfy twice a day – a problem that people with schizophrenia frequently struggle to keep up, studies show.

“That’s a big limitation,” Nate Sutera, a psychiatric pharmacist at the University of Nebraska Medical Center in Omaha, told the website.

Sutera also pointed out that many antipsychotics are long lasting – needing only a few doses annually.

The cost is also a concern for many.

It also isn’t a silver bullet.

Common side effects from Cobenfy in trials included vomiting, nausea, constipation, among others.

The FDA said Cobenfy should not be prescribed to patients with urinary retention, or those with moderate or severe kidney or liver disease.

Bristol says it expects to see significant utilisation of the drug by the end of 2025.

With inputs from agencies