ABSTRACTS 309

dasotraline 6 mg in the completer population (P<0.05; methadone; he immediately reported improvement in post-hoc analysis) but was not significant for either dose depressive symptoms and a reduction in pain. He was of dasotraline vs. placebo when drop-outs were included titrated on BPN-NAL and continued to report diminished in the analysis. The most common adverse events on pain and resolution of depression. Furthermore, his dasotraline 6 mg/d and 4 mg/d were combined irritability was lessened and he newly cooperated with (early, middle, late), dry mouth, headache, decreased staff, participating in unit activities. Upon discharge, he appetite, , and . Changes in systolic and exhibited stable mood, adequate pain control and the diastolic blood pressure were minimal. Mean baseline to elimination of suicidal thoughts as well as a proactive endpoint changes in supine pulse rate on dasotraline drive for substance abuse treatment. 6 mg/d and 4 mg/d vs. placebo was +6.2 bpm and +4.8 This case describes the significance of BPN on relieving vs. +0.2 bpm. psychic pain and stabilizing mood in a chronically suicidal patient. We speculate that BPN’s pharmacokinetic prop- CONCLUSIONS: In this 12-week, placebo-controlled, fixed- erties terminate the cycle of short-term -induced dose study, treatment with dasotraline 6 mg/d was asso- analgesia and euphoria with opioid withdrawal-induced ciated with a significant reduction in frequency of binge- hyperalgesia and dysphoria. This results in a steady treat- eating days per week; efficacy was not demonstrated for ment of pain, as well as maintaining the dopaminergic the 4 mg dose. Treatment with both doses of dasotraline system, symptomatically translating to mood stabilization resulted in improvement in the Y-BOCS-BE and the and annulling suicidal ideation. BE-CGI-S. Dasotraline was safe and generally well- tolerated at both doses; most common adverse events were insomnia, dry mouth and headache. 172 Clinicaltrials.gov: NCT03107026 Funding Acknowledgements: Supported by funding A Phase 3, Multicenter Study to Assess the from Sunovion Pharmaceuticals Inc. Long-Term Safety, Tolerability, and Efficacy of Olanzapine/Samidorphan in Patients with Schizophrenia 171 1 1 Buprenorphine – A Treatment for Psychic Pain and Sergey Yagoda, PhD ; Christine Graham, PhD ; Adam Simmons, MPH2; Christina Arevalo, MBA3; Suicidal Ideation? Yansong Cheng, PhD4; and David McDonnell, MD5 1 1 Ori-Michael Benhamou, MD ; Sean Lynch, BA ; and 1 Associate Medical Director, Clinical Research, 1 Lidia Klepacz, MD Alkermes, Inc. 2 1 Psychiatry Department, Westchester Medical Center, Director, Clinical Program Management, Clinical New York Medical College, Valhalla NY Operations, Alkermes, Inc. 3 Senior Clinical Trial Manager, Clinical Operations, ABSTRACT: Buprenorphine (BPN) is an opiate medication Alkermes, Inc. 4 that is increasingly used in the management of Opioid Use Associate Director, Biostatistics, Alkermes, Inc. 5 Executive Medical Director, Clinical Science, Alkermes Disorder and pain disorders. This case report highlights Pharma Ireland Limited the acute efficacy of using buprenorphine-naloxone (BPN-NAL) to reverse anhedonia and suicidal ideation ABSTRACT: Background: ALKS 3831, a combination of in an individual with OUD, chronic pain and severe olanzapine and samidorphan (OLZ/SAM), is in develop- suicide attempts. ment for the treatment of schizophrenia and is intended We present a case of a 39-year-old male with a history of to provide the efficacy of olanzapine while bipolar disorder, several lethal suicide attempts and mitigating olanzapine-associated weight gain. We report polysubstance abuse, who presented to the hospital after the safety, tolerability, and efficacy of OLZ/SAM in self-immolation, burning 45% total body surface area. He patients with schizophrenia in a phase 3, 52-week, was admitted to the burn unit for three months, reporting open-label extension study. continual anhedonia, suicidal ideation, and flashbacks of seeing and feeling himself on fire. He also endorsed METHODS: Patients aged 18–70 years who completed a chronic pain and hopelessness. previous phase 3, 4-week, inpatient acute efficacy study Upon transfer to the behavioral health unit, his symptoms were switched from OLZ/SAM, olanzapine, or placebo to persisted, despite trials of , mirtazapine, OLZ/SAM. Study assessments included adverse events , oxycodone and prazosin. In consultation (AEs), weight, clinical laboratory testing, and Positive with pain management, he was initiated on sublingual and Negative Syndrome Scale (PANSS) and Clinical BPN-NAL 8mg-2mg treatment as a transition from Global Impression-Severity (CGI-S) scores.

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