A groundbreaking new drug to treat schizophrenia called Cobenfy, owned by pharmaceutical firm Bristol Myers Squibb, has been approved in the US and it is claimed it could change the lives of millions

Brits scientists says a groundbreaking new schizophrenia drug “has the potential to change the lives of millions of people”.

The revolutionary treatment, hailed as a “major advance”, introduces an entirely new approach to managing the condition, which can lead to terrifying hallucinations, delusional thoughts and social withdrawal.

The US Food and Drug Administration (FDA) has now given the green light to the new drug Cobenfy, owned by pharmaceutical giant Bristol Myers Squibb, on Friday. The FDA’s endorsement was based on data from two studies showing patients experienced fewer symptoms of schizophrenia.

The medication is the first approved antipsychotic to target receptors associated with the cholinergic neurotransmitter system in the brain and body, which plays a crucial role in learning and memory, digestion, heartbeat control, blood pressure, movement and other functions. In the UK, the University of Oxford has announced plans to begin trials on the compound next year.

A spokesperson for Bristol Myers Squibb said that so far, the drug has only been submitted to the FDA, but they continue “to evaluate our opportunities outside of the US”. It’s common for pharmaceutical companies to apply for FDA approval before seeking approval in other countries, including the UK.

Dr Lynsey Bilsland, head of mental health translation at Wellcome in the UK, which funded early studies into Cobenfy, said: “It works in a completely different way from any other currently used schizophrenia drugs. It has the potential to change the lives of millions of people.” Schizophrenia is commonly treated with antipsychotics.”

“While these can be effective in managing symptoms like hallucinations and delusions, they do not address other life-limiting symptoms such as social withdrawal and memory problems. Cobenfy has the potential to address all of the above symptoms and also has fewer side-effects such as sleepiness and weight gain and therefore could be game-changing, especially for those for whom other drugs do not work.”

“Wellcome supports mental health research to drive transformation in early intervention for anxiety, depression and psychosis. Cobenfy is an outstanding example of how science can drive forward more effective mental health treatments in our lifetimes.”

Dr Robert McCutcheon, from the department of psychiatry at the University of Oxford, said: “This is a major advance it is the first treatment for schizophrenia with a novel target for 70 years. Current treatments are ineffective for many of the symptoms of schizophrenia we need compounds with novel mechanisms of action.”

“All other treatments work by targeting dopamine receptors. This is the first treatment that has a different target. We hope this may mean it can help people who don’t respond to standard treatments. We will be running the first UK trial of this compound in Oxford, starting in 2025.”

Dr Sameer Jauhar, senior clinical lecturer in affective disorders and psychosis, and consultant psychiatrist at King’s College London and the Maudsley NHS Foundation Trust, commented on the challenges of treating schizophrenia: “Schizophrenia can be a devastating illness for people and their families, and the effects on society are significant.”

He elaborated on treatment options, noting that “We do have effective treatments, and the pharmacological treatments are a foundation for holistic care (which includes psychosocial interventions).” Jauhar highlighted the drawbacks of current treatments, saying, “Unfortunately, currently available antipsychotics have significant side-effects, which include weight gain and movement effects, and this can affect people’s concordance with treatment.”

He continued, “All currently licensed antipsychotics exert effects on the dopamine system, and this has been the case for at least 50 years.” The psychiatrist also pointed out past disappointments in research: “We have had false dawns before, despite significant efforts in the field (with significant financial investment), phase three trials of newer compounds have so far been disappointing.”

However, he expressed enthusiasm for a new development, stating, “This novel treatment is the first of its kind, which does not act directly on the dopamine system, with good phase three trial data.” Concluding his insights, Dr Jauhar expressed optimism: “In my opinion, as a clinician and researcher, this is possibly one of the most exciting developments in our field, and I am very excited about this.”

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