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Cameron Solnordal says the medication for schizophrenia, a complex mental health condition that he lives with, can be burdensome.
A patron of the mental health organisation SANE, Solnordal told SBS News the sedentary effects of antipsychotic medications and the weight gain they commonly cause can disrupt life and turn people off taking them.
Solnordal says that when he first started taking medication for schizophrenia two decades ago, he gained around 40kg in the first few years.
“When you’re still learning about how the medication affects you, and if you’re a new patient, you’ll pack on that weight because as well as feeling really, really tired and really sedated, you’re eating all the time as just part of a coping mechanism,” he said.
“It has such a massive sedating effect. When people describe not wanting to take it, it’s because they hate the way it makes them feel — that is the number one reason.”
Recently, a new drug was approved for the treatment of schizophrenia by the United States Food and Drug Administration (FDA). It’s the first time in more than 70 years that an entirely new class of drugs has been approved for the treatment of the condition.
Cobenfy (originally referred to as KarXT) is a combination therapy of two different drugs: xanomeline and trospium.
The drug targets a different set of receptors in the brain than the existing antipsychotic medications currently used to treat schizophrenia.
While current medications act on the brain’s dopamine system, Cobenfy targets the cholinergic system, which plays a vital role in memory, digestion, heartbeat, blood pressure and movement.
Professor Ashley Bush, a researcher at the Florey Institute of Neuroscience and Mental Health in Melbourne, told SBS News he is “very excited” about the FDA’s decision to approve Cobenfy.
“I think it raises hope. The psychiatry community is cautiously optimistic that this might be a really new great asset to add to the toolkit for schizophrenia. I think it raises hope for both the patient and for the psychiatrist,” he said.
What is schizophrenia?
Schizophrenia is a complex mental health condition that affects approximately 1 per cent of people, amounting to around 200,000 people in Australia and approximately 24 million people worldwide.
It’s characterised by delusions, hallucinations, disorganised speech and behaviour and catatonic behaviour (lack of response to surroundings or people).
The symptoms of schizophrenia are typically classified into positive symptoms, which include hallucinations or delusions, and negative symptoms, which include diminished emotional expression and social withdrawal.
What medications are used to treat schizophrenia?
There are currently two types of drugs that are used to treat schizophrenia, including ‘typical’ antipsychotics, which were the first generation of medications for schizophrenia developed in the 1950s, and ‘atypical’ antipsychotics, which were developed in the 1990s.
Typical antipsychotics include medications such as Chlorpromazine, which was the first antipsychotic drug developed from compounds used for treating allergies and in anaesthesia.
Atypical antipsychotics include medications such as Clozapine and Risperidone.
However, the side effects of these drugs can be broad-ranging and debilitating. Antipsychotics have been shown to cause significant weight gain, type 2 diabetes, raised cholesterol, life-threatening constipation, and lower white blood cell count.
Arthur Christopoulos, dean of the faculty of Pharmacy and Pharmaceutical Sciences at Monash University, told SBS News existing antipsychotics are “dirty drugs” because they target a large number of receptors and result in a lot of side effects.
“[Cobenfy] is far cleaner,” he said. “It’s a more targeted medicine.”
Where did Cobenfy come from?
Christopoulos said the journey to Cobenfy’s approval started approximately three decades ago after pharmaceutical researchers discovered molecules that could selectively target receptors known to be important in regulating neurological effects linked to Alzheimer’s disease and schizophrenia.
The drug xanomeline was originally tested in Alzheimer’s patients but the trials failed due to significant side effects. However, they showed that the drugs significantly reduced symptoms of psychosis.
Later, xanomeline was paired with trospium to alleviate unwanted side effects and this combination became the drug that has now been approved as Cobenfy.
Christopoulos and other Monash University researchers were involved in a global research effort to develop the drug.
Christopoulos said Cobenfy can be considered an “addition” to current antipsychotic medications and may be used in combination with them.
“Targeting this receptor system, it’s a game changer,” he said.
While the trials that led to its approval in the US were only five weeks long, the FDA said patients who received Cobenfy “experienced a meaningful reduction in symptoms” compared to the placebo group.
Prescribing information for the drug warns that it can cause urinary retention, increased heart rate, and decreased gastric movement, and is not recommended for patients with liver impairment.
Christopoulos said that while it may not be a “panacea” it presents a completely different option for medication.
“It’s going to have a significant impact on the lives of people suffering with schizophrenia in Australia and internationally,” he said.
“If I had to choose, I’d rather take this drug than existing antipsychotics.”
Christopoulos said that it’s still too early to tell if the drug will help to treat what is known as ‘treatment-resistant schizophrenia’, where people continue experiencing symptoms despite the use of antipsychotic medication.
Treatment-resistant schizophrenia affects approximately one-third of people diagnosed with the condition.
When will it be available in Australia?
Christopoulos said it’s unclear when Cobenfy will be approved by the Therapeutic Goods Administration (TGA) in Australia but said “it will happen”.
He said there are fast-tracked pathways for TGA approval but it’s uncertain whether they will be used.
A spokesperson for the TGA told SBS News it has not received an application to register Cobenfy on the Australian Register of Therapeutic Goods yet.
“The TGA is aware that the United States Food and Drug Administration has approved Cobenfy. Should the TGA receive an application, it is important to note that the TGA will independently review all data and make its decision based on the Australian context,” they said.
Christopoulos also said that, without listing on the Pharmaceutical Benefits Scheme, the drug could be prohibitively expensive for some people.
As for Australians living with schizophrenia, Solnordal said many people may be relieved by the arrival of a new medication option.
“If someone sat down and said ‘Let’s try and do something better with schizophrenia and the treatment’ then of course people are going to stick their heads up and say ‘finally!'”
“It’s such a make-do-with-what-we’ve-got diagnosis … we just manage day-to-day.”