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New schizophrenia drug approved for the first time in 70 years

by Universalwellnesssystems
Cameron Solnoldal says medication to treat his complex mental illness, schizophrenia, can be a burden.
Solnordal, a patron of the mental health organization SANE, told SBS News that the sedentary effects of antipsychotics and the weight gain commonly caused by antipsychotics can interfere with life and make it difficult for people to take antipsychotics. He said there is a possibility that he will stop taking his medication.
Solnoldal said that when he first started taking schizophrenia medication 20 years ago, he gained about 100 pounds in the first few years.

“I’m still learning how the medication affects me, and as a new patient, not only do I feel very tired and very sedated, but I’m also eating all the time,” she says. You’re going to put on that weight.” It’s just part of the coping mechanism,” he said.

“It has a huge sedative effect. When people say they don’t want to drink it, it’s because they don’t like the way it makes them feel. That’s the number one reason.”
A new drug was recently approved by the U.S. Food and Drug Administration (FDA) to treat schizophrenia. This is the first time in more than 70 years that a completely new class of drugs has been approved to treat this condition.
Cobenfy (originally called KarXT) is a combination therapy of two different drugs: zanomeline and trospium.
The drug targets a different set of receptors in the brain than existing antipsychotic drugs currently used to treat schizophrenia.
While current drugs act on the brain’s dopamine system, Cobenfi targets the cholinergic system, which plays an important role in memory, digestion, heart rate, blood pressure, and movement.

Professor Ashley Bush, a researcher at Melbourne’s Florey Institute of Neuroscience and Mental Health, told SBS News she was “very excited” about the FDA’s decision to approve Cobenfi.

“I think this is encouraging. The psychiatric community is cautiously optimistic that this may be a really great new asset to add to the schizophrenia toolkit. “I think it’s encouraging for both psychiatrists and psychiatrists,” he said.

What is schizophrenia?

Schizophrenia is a complex mental illness that affects approximately 1% of the population, approximately 200,000 people in Australia and 24 million people worldwide.
It is characterized by delusions, hallucinations, incoherent speech, and catatonic behavior (unresponsiveness to surroundings and people).

Symptoms of schizophrenia are usually divided into positive symptoms, such as hallucinations and delusions, and negative symptoms, such as decreased emotional expression and social withdrawal.

What drugs are used to treat schizophrenia?

There are currently two types of drugs used to treat schizophrenia: “typical” antipsychotics, the first generation of schizophrenia drugs developed in the 1950s; It is an “atypical” antipsychotic drug developed in
Typical antipsychotics include drugs such as chlorpromazine, the first antipsychotic drug developed from compounds used to treat allergies and anesthesia.

Atypical antipsychotics include drugs such as clozapine and risperidone.

However, the side effects of these drugs can be extensive and debilitating. Antipsychotics have been shown to cause significant weight gain, type 2 diabetes, elevated cholesterol, life-threatening constipation, and low white blood cell counts.
Monash University School of Pharmacy Dean Arthur Christopoulos told SBS News that existing antipsychotic drugs are “dirty drugs” because they target a large number of receptors and cause many side effects.

”[Cobenfy] “It’s much cleaner. It’s a more targeted drug,” he said.

Where does Cobenfi come from?

Christopoulos said after pharmaceutical researchers discovered a molecule that can selectively target receptors known to be important in controlling neurological effects associated with Alzheimer’s disease and schizophrenia. He said the road to approval of Cobenfi began about 30 years ago.
The drug xanomeline was originally tested in Alzheimer’s patients, but the trial failed due to serious side effects. However, they showed that the drug significantly reduced symptoms of psychosis.
Zanomerine was then combined with trospium to reduce unwanted side effects, and this combination resulted in the drug currently approved as Cobenfi.
Mr Christopoulos and other Monash University researchers took part in a global research effort to develop the drug.
Christopoulos said Cobenfi could be considered an “add-on” to current antipsychotic drugs and used in combination with them.
“Targeting this receptor system is a game changer,” he said.

Although the trial that led to U.S. approval lasted just five weeks, the FDA said patients who received Cobenfi “experienced a significant reduction in symptoms” compared to those in the placebo group.

The drug’s prescribing information warns that it can cause urinary retention, increased heart rate, and decreased gastric motility and is not recommended for patients with liver impairment.
Christopoulos said it may not be a “panacea,” but it does offer a completely different option when it comes to dosing.
“It will have a significant impact on the lives of people living with schizophrenia in Australia and around the world,” he said.
“If I had to choose, I’d rather take this drug than any existing antipsychotic medication.”
Christopoulos said it was too early to tell whether the drug would help treat so-called “treatment-resistant schizophrenia,” where symptoms persist despite the use of antipsychotic drugs.

Treatment-resistant schizophrenia affects approximately one-third of people diagnosed with the condition.

When will it be available in Australia?

Mr Christopoulos said it was unclear when Cobenfi would be approved by Australia’s Therapeutic Goods Administration (TGA), but “it will happen”.
He said there was an expedited path to TGA approval, but it was unclear whether it would be used.
A TGA spokesperson told SBS News that it had not yet received an application to register Cobenfi on the Australian Therapeutic Goods Register.
“The TGA is aware that the US Food and Drug Administration has approved Cobenfi. If the TGA receives an application, the TGA will independently consider all the data and make a decision based on the Australian situation. “It is important to keep in mind that,” they said. .
Christopoulos also said the drug could be prohibitively expensive for some people if it were not listed on the Pharmaceutical Benefits Scheme.
For Australians living with schizophrenia, Mr Solnoldal said many may find relief from the arrival of new drug options.
“If someone sat down and said, ‘Let’s make schizophrenia and its treatment better,’ of course people would look up and say, ‘Finally!'”

“It’s kind of like getting by with the diagnosis that we have…We just get through the days.”

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