New Oral Therapy Announced to Treat Patient With Schizophrenia

Roger McIntyre, MD, FRCPC, professor of psychiatry and pharmacology, University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada, answers questions on the newly released oral therapy for the treatment of schizophrenia.

Question: Why is it important to have an oral therapy for people with schizophrenia?

Answer: Oral therapies provide ease-of-use and scale. This is a chronic, lifelong illness, and people need treatments that are easy to administer. We need new oral, available treatments that are acceptable, tolerated, and effective for schizophrenia.

Q: How is olanzapine and samidorphan different from other treatments out there for patients with schizophrenia?

A: Samidorphan is a new chemical entity with demonstrated efficacy and weight gain mitigation—a lower weight gain liability than olanzapine alone. This is important because people who have schizophrenia are not only more affected by obesity-related conditions, but they’re also more likely to die because of obesity-related causes. So, with common conditions that lead to morbidity and mortality, we need treatment options that are more effective and that have lower weight gain liability. Olanzapine’s efficacy is proven safe, and the combination of olanzapine and samidorphan has a lower weight gain liability than olanzapine alone.

Q: Please give an overview of the results and data from the ENLIGHTEN-1 and ENLIGHTEN-2 studies.

A: We have ENLIGHTEN-1, the efficacy study, and we have ENLIGHTEN-2, the weight efficacy study. This drug has shown efficacy in individuals who are affected by schizophrenia vs placebo, and it has shown weight efficacy, meaning it has a lower weight gain liability in 2 separate studies that were done on olanzapine and samidorphan. It’s important to emphasize we need efficacious treatments, but we also need treatments that don’t have the burden of weight gain that we see with olanzapine alone. We saw significant weight gain mitigation—in fact, that was seen very early on in the treatment course within the first 4 to 6 weeks. There was a separation between the olanzapine and combination of olanzapine and samidorphan. We have a nice combination of efficacy as well as weight gain mitigation data with this new agent.

Q: What advice would you give clinicians for starting to incorporate olanzapine and samidorphan into their current treatment plan?

A: I think we need options. Clinicians have never questioned the efficacy of olanzapine. Now, they have olanzapine with lower weight gain liability. Clinicians and patients and families are always looking for new options. They are looking for options that are effective and that will be well-tolerated. Now, I see olanzapine and samidorphan as an alternative to other treatments—this is clearly another treatment for anyone with schizophrenia where weight gain is concerned.

Q: Are there any contraindications in patients with schizophrenia?

A: The only contraindication would be the contraindication inherent in each medication. For example, if a person had a hypersensitivity allergic reaction to olanzapine or to samidorphin, that would obviously be a contraindication. Beyond that, there are none. (Olanzapine and samidorphan is contraindicated in patients using opioids or undergoing acute opioid withdrawal.)

Dr. Roger McIntyre is a Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada.

Dr. McIntyre is also Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada. Dr. McIntyre is also Director as well as Co-Chair of the Scientific Advisory Board of the Depression and Bipolar Support Alliance (DBSA) from Chicago, Illinois, USA. Dr. McIntyre is also Professor and Nanshan Scholar at Guangzhou Medical University, and Adjunct Professor College of Medicine at Korea University. Dr. McIntyre is also Clinical Professor State University of New York (SUNY) Upstate Medical University, Syracuse, New York, USA and Clinical Professor Department of Psychiatry and Neurosciences University of California School of Medicine, Riverside, California, USA. Dr. McIntyre is the founder of the Canadian Rapid Treatment Centre of Excellence (CRTCE) and the CEO of Braxia Scientific Corp.

Dr. McIntyre was named by Clarivate Analytics in 2014, 2015, 2016, 2017, 2018, 2019 and 2020 as one of “The World’s Most Influential Scientific Minds”. This distinction is given by publishing the largest number of articles that rank among those most frequently cited by researchers globally in 21 broad fields of science and social science during the previous decade. Dr. McIntyre has published more than 740 articles and has edited and co-edited several textbooks on mood disorders.

Dr. McIntyre is involved in multiple research endeavours which primarily aim to characterize the phenomenology, neurobiology, and novel therapeutics of mood disorders.  Dr. McIntyre has been especially interested in identifying innovative, rapid acting psychotropic treatments for mood disorders. Dr. McIntyre’s research has also extended into public health and implementation research at the population-based level.

Dr. McIntyre is extensively involved in medical education. He is a highly sought-after speaker at both national and international meetings. He has received several teaching awards from the University of Toronto, Department of Psychiatry and has been a recipient of the joint Canadian Psychiatric Association (CPA)/Council of Psychiatric Continuing Education Award for the Most Outstanding Continuing Education Activity in Psychiatry in Canada.

Dr. McIntyre has also contributed extensively to clinical practice guidelines. For example, Dr. McIntyre is the lead author the Florida Best Practice Psychotherapeutic Medication Guidelines for Adults with Major Depressive Disorder and Bipolar Disorder. In addition, Dr. McIntyre is also the lead author of the International Expert Opinion on the Available Evidence and Implementation of Ketamine and Esketamine in Mood Disorders. Dr. McIntyre is also a contributor to the CANMAT guidelines for the treatment of Depressive Disorders and Bipolar Disorders as well as the Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines for Mood Disorders.

Dr. McIntyre completed his medical degree at Dalhousie University.  He received his Psychiatry residency training and Fellowship in Psychiatric Pharmacology at the University of Toronto.