OBJECTIVE Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia. METHODS In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study. RESULTS 200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were -17.4 for AL and -20.1 for PP at week 4 (both groups, P less then 0.001) and continued to decline at weeks 9 (AL, -19.8; PP, -22.5) and 25 (AL, -23.3; PP, -21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%). CONCLUSIONS AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting. FUNDING ACKNOWLEDGEMENTS This study was funded by Alkermes, Inc.BACKGROUND Asenapine is a 2nd-generation antipsychotic currently marketed as a sublingual (SL) tablet in the US for the treatment of schizophrenia. HP-3070, asenapine transdermal system, is a patch for treatment of schizophrenia in adults. Low- and high- HP-3070 doses deliver asenapine concentrations that are similar to SL asenapine 5 mg BID and 10 mg BID, respectively, but with fewer peak and trough fluctuations. METHODS In this Phase 3, randomized, double-blind, placebo (PBO)-controlled, 6-week inpatient study, adults with schizophrenia having baseline Positive and Negative Syndrome Scale (PANSS) total score ≥80 and Clinical Global Impression-Severity of Illness Scale (CGI-S) score ≥4 were randomized 111 to HP 3070 high-dose, HP-3070 low-dose, or PBO.The primary efficacy objective was Week 6 PANSS score change from baseline (CFB) vs PBO.The key secondary objective was Week 6 CGI-S CFB vs PBO. Safety assessments included treatment-emergent adverse events (TEAEs), laboratory results, vital signs, dermal safetcal Co.STUDY OBJECTIVE Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged exposure to antipsychotics and other dopamine receptor blocking agents. Valbenazine is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for the treatment of TD in adults. Using data from a long-term study (KINECT 3; NCT02274558), the effects of once-daily valbenazine (40 mg, 80 mg) on TD were assessed using the Abnormal Involuntary Movement Scale (AIMS) in participants who were early responders based on subjective measures, including patient self-report (Patient Global Impression of Change [PGIC]) or clinician judgment (Clinical Impression of Change-Tardive Dyskinesia [CGI-TD]). METHODS Data from KINECT 3 (6-week double-blind, placebo-controlled [DBPC] period; 42-week double-blind extension) were analyzed post hoc. Long-term outcomes included mean change from baseline to Week 48 in AIMS total score (sum of items 1-7) and AIMS response (≥50% total score ims similar to those who did not achieve early CGI-TD improvement (-4.2 [n=31] vs -3.5 [n=45]). AIMS response at Week 48 was also similar in those who achieved early PGIC and CGI-TD improvement (40% and 42%, respectively) compared to those who did not achieve early PGIC and CGI-TD improvement (39% and 38%, respectively). CONCLUSIONS Results from this long-term valbenazine trial indicate that many participants achieved at least minimal patient- and clinician-reported improvement at Week 2. AIMS outcomes at Week 48 demonstrated long-term reductions in TD severity regardless of early response. More research is needed to understand the association between early improvement and long-term treatment effects, but early non-improvement based on subjective measures may not be predictive of long-term treatment failure. PRESENTED International Congress of Parkinson’s Disease and Movement Disorders; September 22-26, 2019; Nice, France. FUNDING ACKNOWLEDGEMENTS This study was sponsored by Neurocrine Biosciences, Inc.Buprenorphine (BPN) is an opiate medication that is increasingly used in the management of Opioid Use Disorder and pain disorders. JTC-801 This case report highlights the acute efficacy of using buprenorphine-naloxone (BPN-NAL) to reverse anhedonia and suicidal ideation in an individual with OUD, chronic pain and severe suicide attempts.We present a case of a 39-year-old male with a history of bipolar disorder, several lethal suicide attempts and polysubstance abuse, who presented to the hospital after self-immolation, burning 45% total body surface area. He was admitted to the burn unit for three months, reporting continual anhedonia, suicidal ideation, and flashbacks of seeing and feeling himself on fire. He also endorsed chronic pain and hopelessness.Upon transfer to the behavioral health unit, his symptoms persisted, despite trials of quetiapine, mirtazapine, methadone, oxycodone and prazosin. In consultation with pain management, he was initiated on sublingual BPN-NAL 8mg-2mg treatment as a transition from methadone; he immediately reported improvement in depressive symptoms and a reduction in pain. He was titrated on BPN-NAL and continued to report diminished pain and resolution of depression. Furthermore, his irritability was lessened and he newly cooperated with staff, participating in unit activities. Upon discharge, he exhibited stable mood, adequate pain control and the elimination of suicidal thoughts as well as a proactive drive for substance abuse treatment.This case describes the significance of BPN on relieving psychic pain and stabilizing mood in a chronically suicidal patient. We speculate that BPN’s pharmacokinetic properties terminate the cycle of short-term opioid-induced analgesia and euphoria with opioid withdrawal-induced hyperalgesia and dysphoria. This results in a steady treatment of pain, as well as maintaining the dopaminergic system, symptomatically translating to mood stabilization and annulling suicidal ideation.