Findings from Patient Surveys Underscore Need for New Antipsychotic Treatments with Reduced Side Effects

CLEVELAND – Results from two recently completed online surveys evaluating the treatment experiences of people living with schizophrenia (n=200) and bipolar I disorder (n=200), including side effects associated with oral antipsychotic medications, were presented at the 32nd Annual Psych Congress (Psych Congress), which took place Oct. 3-6, 2019 in San Diego.

"These survey data offer valuable insights into the experiences and concerns of people living with schizophrenia and bipolar I disorder and underscore the need for expanded research and development of treatment options that offer clinical efficacy with a more tolerable side-effect profile," said study investigator, Martha Sajatovic, MD, Director of the Neurological and Behavioral Outcomes Research Center at University Hospitals Cleveland Medical Center.

Key findings related to survey respondents' prior experiences with antipsychotic medications include:

• Nearly all participants (98 percent for both schizophrenia and bipolar I disorder) reported having experienced at least one or more treatment side effect;
•  For both patient populations, dislike of side effects was the most common reason cited for non-adherence to oral antipsychotic medications;
• Weight gain was reported as the most bothersome (combining survey responses of "very bothersome" and "extremely bothersome") side effect for both patient populations;
• Respondents in both patient populations reported that side effects associated with oral antipsychotic medications had a negative impact on their social functioning, including work, social activities, relationships with friends and family, and romantic relationships.

"Oral antipsychotic medications serve as a mainstay treatment option for people living with serious mental illnesses like schizophrenia and bipolar I disorder. However, as these survey results demonstrate, treatment side effects are highly common and can have significant impacts on patients' day-to-day lives," said study investigator Dawn L. Velligan, PhD, Department of Psychiatry and Co-Chief of the Division of Schizophrenia and Related Disorders at UT Health San Antonio.

The surveys also sought to capture participant preferences:

• When asked to consider trade-offs between improvements in symptoms versus side effects for a hypothetical new oral antipsychotic medication, 67 percent of the people with schizophrenia who were surveyed selected improvement in symptoms over improvements in side effects, highlighting a desire for highly efficacious therapies;
•  Respondents with bipolar I disorder ranked anxiety, weight gain and "feeling like a zombie" as the top three side effects they would most want to avoid in a potential new oral antipsychotic medication.

The study was funded by Alkermes plc, which is planning to file a New Drug Application in the fourth quarter for ALKS 3831 (olanzapine/samidorphan) for both bipolar 1 and schizophrenia. ALKS 3831 is designed to provide the efficacy of olanzapine without the associated weight gain.