2020 Annual Meeting POSTER ABSTRACTS
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ASCP 2020 Annual Meeting POSTER ABSTRACTS (18 more at www.ascpmeeting.org) Disclaimer: The content displayed in these publications is that of the presenters and does not necessarily reflect the opinions of the American Society of Clinical Psychopharmacology (ASCP) or Physicians Postgraduate Press, Inc. All materials were provided by ASCP. The presenters hold the copyright. Friday, May 29, 2020 Poster Session I F1. LONG-TERM EFFICACY AND SAFETY OF LEMBOREXANT IN ADULTS WITH INSOMNIA DISORDER: RESULTS ACROSS 12 MONTHS FROM SUNRISE- 2 Jane Yardley1, Mikko Kärppä2, Yuichi Inoue3, Kate Pinner1, Carlos Perdomo1, Gleb Filippov1, Kohei Ishikawa1, Naoki Kubota1, Margaret Moline*1 1Eisai Co, Ltd., 2Oulo University Hospital and University of Oulu, 3Tokyo Medical University, Abstract: Introduction: Lemborexant (LEM) is a dual orexin receptor antagonist (DORA) recently approved in the US and Japan for treatment of insomnia (Rosenberg et al, 2019; Hoyer et al, 2018). SUNRISE-2 (NCT02952820; E2006-G000-303) was a Phase 3 study that demonstrated significant benefit of LEM versus placebo (PBO) on patient-reported (subjective) sleep onset and maintenance outcomes. Here we present the 12-month efficacy and safety data for LEM from SUNRISE-2. Methods: This randomized, double-blind, placebo-controlled (first 6 months [Treatment Period 1]), 12-month global Phase 3 study enrolled adults aged ≥18y with insomnia disorder defined per DSM-5 criteria. During Treatment Period 1, subjects were randomized to PBO or LEM (5mg, [LEM5]; 10mg, [LEM10]). During Treatment Period 2 (second 6 months), PBO subjects were re-randomized to LEM5 or LEM10 (not reported here) and LEM subjects continued with their assigned dose. Changes from baseline in subjective sleep parameters (sleep onset latency [sSOL], sleep efficiency [sSE], wake after sleep onset [sWASO]) were calculated based on sleep diary data. P-values were based on mixed-effect repeated measurement analysis evaluating least squares mean treatment differences for placebo versus LEM at Month 6. Results: The Full Analysis Set included 949 subjects (Period 1: Placebo, n=318; LEM5, n=316; LEM10, n=315). At the end of Treatment Period 1 (Month 6) 251 and 226 subjects continued LEM5 and LEM10, respectively. Median sSOL (min) was significantly decreased (improved) with LEM5 (−21.8) and LEM10 (−28.2) versus PBO (−11.4; both P<0.0001) at Month 6; improvements were sustained at Month 12 (LEM5, −25.9; LEM10, −33.6). Mean (SD) increases in sSE (%) were significantly greater (improved) with LEM5 (15.3 [14.6]) and LEM10 (15.6 [15.6]) versus PBO (10.4 [13.8]; both P≤0.0001) at Month 6; increases were maintained at Month 12 (LEM5, 15.8 [14.4]; LEM10, 17.9 [16.1]). Mean (SD) decreases in sWASO (min) were significantly greater with LEM5 (−51.5 [67.3]) and LEM10 (−48.1 [68.6]) versus PBO (−32.1 [55.3]; P<0.001, P<0.05, respectively) at Month 6; decreases were maintained at Month 12 (LEM5, −53.1 [61.5]; LEM10, −58.0 [71.1]). The majority of treatment-emergent adverse events (TEAEs) were mild or moderate. The most common TEAEs across the year of treatment (occurring in >10% for either LEM group), with LEM5 and LEM10, respectively, were nasopharyngitis (13.7%, 13.4%), somnolence (9.6%, 14.3%), and headache (11.1%, 9.2%). No deaths were reported. Conclusions: Improvements to subjective sleep outcomes observed with LEM at 6 months were sustained over 12 months; LEM was well tolerated. These data from SUNRISE-2 suggest that LEM is a potential long-term treatment option for patients with chronic insomnia. 1 SUPPORT: Eisai Inc. F2. PUBLIC IMAGE AND SENTIMENT TOWARD THE PHARMACEUTICAL INDUSTRY: WHAT CAN WE DO TO REVERSE THE NEGATIVE TREND? Charles Wilcox*1 1Praxis Research Consulting Abstract: In late 2019 a Gallup poll reported that the pharmaceutical industry surpassed the oil industry, hitting "rock bottom," in terms of (public) trust. This fact has an undisputed negative impact on both clinical trial recruitment and enrollment; it may also adversely affect retention as well. There are numerous causes and widely publicized examples of behaviors and incidents perpetuating this public sentiment. Strangely, only recently have some excellent public relations efforts and public service announcements (e.g., PSAs) been conceptualized and implemented in an effort to improve the public awareness of, and respect for, our industry, especially as it relates to the clinical research process. In 2014 the European Union (EU) Clinical Trial Regulation requiring Layperson/Plain Language Summaries (PLS) was passed and slated for implementation in 2018; however, due to patient portal-related "technical difficulties," mandatory implementation has been deferred until 2020. Here in the United States, many sponsors have evaluated the pros and cons, as well as the projected costs and perceived benefits, of a voluntary pro-active implementation of a PLS strategy. As of this date, while TransCelerate has published a document titled "Layperson Summaries of Clinical Trials: An Implementation Guide (with recommendations on how to do so in a non-promotional manner)," we remain far from a comprehensive and/or quasi- standardized strategy for the PLS creation and distribution processes. Moreover, voluntary, pro-active, compliance with and/or implementation of a PLS strategy is "low hanging fruit," when it comes to an industry-wide opportunity to help ameliorate the widely-embraced "distrust," as well as better inform and educate our trial participants. This poster presentation will concisely provide publicly accessible resources to help guide smaller companies through the mine-fields of allegations regarding potential "pre-promotional" wrongdoing; it will also highlight how an effective creation and implementation of a PLS strategy will prove to be an exceedingly cost-effective long-term "voluntary" strategy. Furthermore, in the wake of such rampant public distrust, being fueled even further by politics throughout this election year, the timing of this opportunity to further educate and inform trial participants as well as enhance our public image, will also have a positive immediate- and long- term measurable impact on enrollment! While delay is preferable to error(s) in implementation, the 2014 passage of the first applicable- to-PLS regulation has provided us with sufficient time --- and, now published guidelines --- to move forward without further delay. As sponsors, sites and CROs working together vis-a-vis a PLS dissemination process, we can not only utilize this as an opportunity to "Thank" patients, we can do so in a manner which also better educates them whilst bolstering their trust in us. Finally, it will also translate into a heightened willingness to possibly "volunteer again" and potentially "refer-a-friend"!! 2 F3. WHY ARE WE SWITCHING? A RETROSPECTIVE CHART REVIEW STUDY OF REASONS FOR ANTIPSYCHOTIC SWITCH AMONGST FIRST- AND SECOND- GENERATION ANTIPSYCHOTICS Kaksha Varma*1, Daniel Guinart1, Nahal Talasazan1, Georgios Schoretsanitis1, John M. Kane1 1The Zucker Hillside Hospital Abstract: Background and objectives: Antipsychotics are the cornerstone of successful acute treatment and relapse prevention in psychotic disorders. However, despite their efficacy, antipsychotics are prone to frequent switches (1). Previous literature exploring the reasons leading physicians to switch antipsychotic treatments point towards the lack of tolerability/side effects (2). However, the relationship between antipsychotic generation (first- (FGA) vs. second-generation (SGA)) and reasons for medication switch have been less frequently studied. Thus, we aimed to review and characterize antipsychotic medication switches and examine their potential relationship with antipsychotic generation (FGA vs. SGA). Methods: We conducted a systematic retrospective chart review in order to extract data on antipsychotic medication switch for patients treated in the inpatient and outpatient units at the Zucker Hillside Hospital, New York between August 2017 and August 2018. Reasons for every switch were independently extracted by two investigators and categorized to: side effects, lack of efficacy, insurance problems, symptom remission, patient preference, poor adherence, and other. Comparisons between FGA vs. SGA were analyzed using chi-square tests (χ2) with a significance level of 0.05. Statistical analyses were carried out using IBM SPSS Statistics version 12.0. Results: 400 charts were reviewed. 167 antipsychotic switches were detected, of which 159 reported reasons for the switch. A total of 65/159 switches (40.9%) were detected in males and 94/159 (59.1%) in females. 89/159 (56.0%) were reported in white subjects, 46/159 (28.9%) in African American, 16/159 (10.1%) in Asians, 4/159 (2.5%) in subjects of mixed race and race was not provided in 2/159 (1.3%). Regarding the type of antipsychotic, 16/159 (10.1%) were FGA switches, whereas 143/159 (89.9%) were SGA switches. Our analysis showed no significant differences in reasons for switch based on antipsychotic generation (X2= 2.1, p= 0.909). The most common reason for switching overall was found to be side effects, n= 75 (47.2%), followed by a lack of efficacy, n= 34 (21.4%). Patient preference accounted for 23 (14.5%) of the switches, and poor adherence accounted for 12 (7.5%). Additionally, insurance problems accounted for 6 (3.8 %). Symptom remission was listed in 1 (0.6%) case and the remaining 8 (5.0%) were for other reasons. Conclusion: In our sample, the majority of antipsychotic switches were related to side effects.