New Oral Therapy Treatment for Bipolar Disorder Recently Announced

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, discusses the newly available oral therapy for the treatment of bipolar disorder.

Question: What has been the standard of pharmacological treatment for patients with bipolar disorder?

A: The standard treatment across America has been second-generation, also referred to as atypical, antipsychotics and, to a lesser extent, anticonvulsants like lithium. During the last 20 years, there has been a rise in trajectory of the use of second-generations in part because of the US Food and Drug Administration (FDA) indication for many atypicals across various phases of bipolar disorder. In America, the most commonly prescribed medications for bipolar I disorder are antipsychotics. Olanzapine and samidorphan is a new chemical entity—antipsychotic combined with an opioid antagonist—that is proven effective. Olanzapine is a proven-to-be-effective monotherapy as well as adjunct to lithium and valproate acutely and also has relapse prevention results, as monotherapies. Olanzapine and samidorphan has all of those indications. 

Q: Why is it important to have an oral therapy for people with bipolar disorder?

A: People need options. We need alternatives. An oral treatment option is greater in scale and easier to administer in outpatients who have what is a very common disorder across America.

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

A: It’s different insofar as olanzapine has demonstrated unequivocal efficacy in mania and mixed episodes recurrence prevention. Olanzapine and samidorphan is different in the sense that it has a lower weight gain liability than olanzapine alone, which has been one of the gold standards in treating mania. 

Q: What research studies and data support this new treatment, and can you briefly describe them?

A: The data from olanzapine and samidorphan have been extrapolated from the weight efficacy data in schizophrenia. The FDA has provided indication both in schizophrenia and acute maintenance treatment of bipolar disorder based on the weight and symptomatic efficacy studies done in schizophrenia. 

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

A: First, shared decision making with patients and families is important. Second, let patients and families know what the options are. Olanzapine and samidorphan is a treatment option for people with bipolar disorder that has less weight gain liability.

Q: Are there any contraindications in patients with bipolar disorder?

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. (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.