2018 NEI Congress | Orlando, Florida
November 9, 2018
Keeping up With the Clinical Advances: Schizophrenia
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Schizophrenia is a debilitating disease, and is often difficult to treat. Some of the most common obstacles to treatment are issues with adherence, effectiveness, and unwanted side effects. At the 2018 NEI Congress, Dr. Jonathan Meyer discussed novel agents in development or recently FDA approved that may aid in many of these challenges. |
One novel agent being investigated is ALKS 3831, a flexible dose of olanzapine and a fixed dose of 10 mg samidorphan. Samidorphan is an opioid antagonist at the µ-opioid receptor, with significant activity at kappa opioid receptors. It is also being investigated for addiction treatment (e.g., alcohol, cocaine). Samidorphan works by blocking opioid receptors involved in the brain reward pathway reinforcement is reduced.
Samidorphan works by blocking opioid receptors involved in the brain reward pathway
Samidorphan shows similar efficacy to naltrexone but with reduced side effects. When co-administration of olanzapine and samidorphan, but not naltrexone mitigated olanzapine-induced weight gain suggesting that the added K-opioid receptor properties may be clinically relevant. In the phase II study, co-administration of samidorphan mitigated olanzapine -associated weight gain, and olanzapine/samidorphan combination had similar antipsychotic efficacy to olanzapine. Phase III is currently ongoing and is a 4-week randomized, double-blind active (olanzapine monotherapy) and placebo-controlled study of ALKS 3831 in acute exacerbation of schizophrenia. The method is a 2-week inpatient treatment (olanzapine titration permitted) followed by 2-week inpatient/outpatient treatment (fixed olanzapine dose). Outcomes are PANSS and Clinical Global Impression-Scale (CGI-S).
References:
Di Petrillo et al. American Psychiatric Association (APA) Annual Meeting, May 5-9, 2018, New York, NY.
Kenny et al. Neuron 2011; 69(4): 664-679.
Simmons et al. APA Annual Meeting, May 5-9, 2018, New York, NY; Potkin et al. APA Annual Meeting, May 5-9, 2018, New York, NY.
Silverman et al. Schizophr Res 2018;195:245-251.
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