Source: United Kingdom – Executive Government & Departments
Scientists comment on the FDA approving Cobenfy (KarXT) for schizophrenia.
Dr Sameer Jauhar, Senior Clinical Lecturer in Affective Disorders and Psychosis, Consultant Psychiatrist, King’s College, London and South London and Maudsley NHS Foundation Trust, said:
“Schizophrenia can be a devastating illness for people and their families, and the effects on society are significant.
“We do have effective treatments, and the pharmacological treatments are a foundation for holistic care (which includes psychosocial interventions).
“Unfortunately currently available antipsychotics have significant side-effects, which include weight gain and movement effects, and this can affect peoples’ concordance with treatment.
“All currently licensed antipsychotics exert effects on the dopamine system, and this has been the case for at least 50 years.
“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.
“This novel treatment is the first of its kind, which does not act directly on the dopamine system, with good phase three trial data.
“The side effect profile from Phase three trials suggests it has less of the side effects noted with current treatments.
“It is acknowledged that these trials are short in duration, and we will need longer-term trials, to inform clinical care.
“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.”
Dr Robert McCutcheon, Wellcome Clinical Research Career Development Fellow, Department of Psychiatry, University of Oxford, said:
Just how significant is this approval in the mental health/ schizophrenia treatment field?
“This is a major advance – it is the first treatment for schizophrenia with a novel target for 70 years.
Why do we need other drug treatments in schizophrenia?
“Current treatments are ineffective for many of the symptoms of schizophrenia, we need compounds with novel mechanisms of action.
What is different about this drug to previous drugs for schizophrenia?
“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 and maybe help the symptoms that aren’t helped by existing treatments.
What does this mean for patients in the UK who may be excited about this news?
“We will be running the first UK trial of this compound in Oxford, starting in 2025.”
Dr Paul Keedwell, Consultant Psychiatrist and Fellow of the Royal College of Psychiatrists, said:
“New candidates for the treatment of this frequently debilitating condition are always welcome. However, the clinical effectiveness needs to be tested in real clinical settings. We also need to know how well it is tolerated given its tendency to cause gastro-intestinal problems in some patients.”
Declared interests
Dr Sameer Jauhar: SJ has given educational talks on psychosis for Behringer=Ingelheim, Sunovian, Janssen, and Lundbeck. He has consulted for LB Pharmaceuticals on antipsychotics. He has sat on a Wellcome Funding Panel, and NICE Technology appraisal panel for treatment of antipsychotic induced movement disorder. He is a Council Member of the British Association for Psychopharmacology (unpaid) and Academic Faculty of the Royal College of Psychiatrists (unpaid).
Dr Robert McCutcheon: RAM has received speaker/consultancy fees from Boehringer Ingelheim, Janssen, Karuna, Lundbeck, Newron, Otsuka, and Viatris, and co-directs a company that designs digital resources to support treatment of mental ill health. I am leading a Wellcome trust funded RCT of the compound in early psychosis.
Dr Paul Keedwell: No conflict of interest.