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Gabapentin Enacarbil Extended& ALCOHOLISM:CLINICAL AND EXPERIMENTAL RESEARCH Vol. 43, No. 1 January 2019 Gabapentin Enacarbil Extended-Release for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo- Controlled, Multisite Trial Assessing Efficacy and Safety Daniel E. Falk , Megan L. Ryan, Joanne B. Fertig, Eric G. Devine, Ricardo Cruz, E. Sherwood Brown , Heather Burns, Ihsan M. Salloum, D. Jeffrey Newport, John Mendelson, Gantt Galloway, Kyle Kampman, Catherine Brooks, Alan I. Green, Mary F. Brunette, Richard N. Rosenthal, Kelly E. Dunn, Eric C. Strain, Lara Ray , Steven Shoptaw, Nassima Ait-Daoud Tiouririne, Erik W. Gunderson, Janet Ransom, Charles Scott, Lorenzo Leggio , Steven Caras, Barbara J. Mason, Raye Z. Litten, and for the National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG) Study Group Background: Several single-site alcohol treatment clinical trials have demonstrated efficacy for immediate-release (IR) gabapentin in reducing drinking outcomes among individuals with alcohol dependence. The purpose of this study was to conduct a large, multisite clinical trial of gabapentin enacarbil extended-release (GE-XR) (HORIZANTÒ), a gabapentin prodrug formulation, to determine its safety and efficacy in treating alcohol use disorder (AUD). Methods: Men and women (n = 346) who met DSM-5 criteria for at least moderate AUD were recruited across 10 U.S. clinical sites. Participants received double-blind GE-XR (600 mg twice a day) or placebo and a computerized behavioral intervention (Take Control) for 6 months. Efficacy analyses were prespecified for the last 4 weeks of the treatment period. Results: The GE-XR and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs. 21.5, respectively, p = 0.157). Similarly, no clini- cal benefit was found for other drinking measures (percent subjects abstinent, percent days abstinent, percent heavy drinking days, drinks per week, drinks per drinking day), alcohol craving, alcohol-related conse- quences, sleep problems, smoking, and depression/anxiety symptoms. Common side-effects were fatigue, dizziness, and somnolence. A population pharmacokinetics analysis revealed that patients had lower gaba- pentin exposure levels compared with those in other studies using a similar dose but for other indications. Conclusions: Overall, GE-XR at 600 mg twice a day did not reduce alcohol consumption or craving in individuals with AUD. It is possible that, unlike the IR formulation of gabapentin, which showed efficacy in smaller Phase 2 trials at a higher dose, GE-XR is not effective in treating AUD, at least not at doses approved by the U.S. Food and Drug Administration for treating other medical conditions. Key Words: Alcohol Use Disorder, Gabapentin Enacarbil Extended-Release, HORIZANT, Randomized Placebo-Controlled Clinical Trial. From the National Institute on Alcohol Abuse and Alcoholism (DEF, MLR, JBF, RZL), Bethesda, Maryland; Department of Psychiatry (EGD), Boston University School of Medicine, Boston, Massachusetts; Section of General Internal Medicine (RC), Department of Medicine, School of Medicine and Boston Medical Center, Section of General Internal Medicine, Boston University, Boston, Massachusetts; Department of Psychiatry (ESB, HB), The University of Texas Southwestern Medical Center, Dallas, Texas; Division of Alcohol and Substance Abuse (IMS, DJN), Depart- ment of Psychiatry and Behavioral Sciences , University of Miami Miller School of Medicine, Miami, Florida; Friends Research Institute (JM, GG), San Francisco, California; Department of Psychiatry (KK, CB), Perelman School of Medicine, Center for Studies of Addiction, University of Pennsyl- vania, Philadelphia, Pennsylvania; Department of Psychiatry (AIG, MFB), Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire; Divi- sion of Addiction Psychiatry (RNR), Stony Brook University, Stony Brook, New York; Mount Sinai St. Luke’s Hospital (RNR), New York, New York; Department of Psychiatry and Behavioral Sciences (KED, ECS), Johns Hopkins University School of Medicine, Baltimore, Maryland; Depart- ment of Psychology and Department of Psychiatry and Biobehavioral Sciences (LR), University of California Los Angeles, Los Angeles, California; Department of Family Medicine and of Psychiatry and Biobehavioral Sciences (SS), David Geffen School of Medicine at UCLA, Los Angeles, Califor- nia; Center for Leading Edge Addiction Research (NA-DT), University of Virginia, Charlottesville, Virginia; Department of Psychiatry and Neurobe- havioral Sciences and Department of Medicine (EWG), University of Virginia School of Medicine, Charlottesville, Virginia; Fast Track Drugs and Biologics (JR, CS), North Potomac, Maryland; Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology (LL), National Insti- tute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, Maryland; Arbor Pharmaceuti- cals, LLC (SC), Atlanta, Georgia; and Department of Neuroscience (BJM), The Scripps Research Institute, La Jolla, California. Received for publication August 1, 2018; accepted October 27, 2018. Reprint requests: Daniel E. Falk, PhD, Division of Medications Development, NIAAA, 5635 Fishers Lane, Room 2045, Bethesda, MD 20892–9304. Tel.: 301-443-0788; E-mail: [email protected] Published 2018. This article is a U.S. Government work and is in the public domain in the USA. DOI: 10.1111/acer.13917 158 Alcohol Clin Exp Re, Vol 43, No 1, 2019: pp 158–169 GABAPENTIN ENACARBIL FOR ALCOHOL USE DISORDER 159 LCOHOL USE DISORDER (AUD) is a highly preva- dependence and comorbid insomnia. In a small study, Anton A lent, highly comorbid disorder, affecting more than 15 and colleagues (2009) found that G-IR (up to 1,200 mg/d for million adults in the United States (https://pubs.niaaa.nih. 39 days) combined with flumazenil, a benzodiazepine recep- gov/publications/AlcoholFacts&Stats/AlcoholFacts&Stats. tor antagonist (20 mg/d for the first 2 days), was associated htm). Advances have been made in medications to treat with an increase in the percentage of days abstinent and a AUD, highlighted by U.S. Food and Drug Administration longer delay to heavy drinking in a subgroup of alcohol- (FDA) approval of 3 medications to treat alcohol depen- dependent individuals (n = 16) who had relatively high pre- dence, specifically disulfiram, oral and long-acting injectable treatment alcohol withdrawal symptoms. In another RCT, naltrexone, and acamprosate. Nonetheless, many people do Anton and colleagues (2011) found that alcohol-dependent not respond to these medications. Thus, efforts have been individuals (n = 150) treated with G-IR (1,200 mg/d) com- made to develop and evaluate new medications (Litten et al., bined with oral naltrexone (50 mg/d) experienced better out- 2015). comes on several measures of drinking, craving, and sleep One promising agent being investigated for AUD treat- than the group taking naltrexone alone or those receiving the ment is gabapentin immediate-release (G-IR). G-IR cur- placebo over the first 6 weeks. rently is approved by the FDA for the treatment of epileptic The present study focuses on gabapentin enacarbil seizures, neuropathic pain, and restless leg syndrome (http:// extended-release (GE-XR) (HORIZANTÒ; Arbor Pharma- www.caremark.com/portal/asset/FEP_Rationale_Gabape ceuticals, LLC, Atlanta, GA), a relatively new, extended- ntin.pdf). The mechanism of action of gabapentin is unclear, release, prodrug formulation of gabapentin approved by the though it appears to have multiple cellular effects, including FDA for the treatment of postherpetic neuralgia (PHN) and selectively blocking voltage-gated calcium channels with the restless legs syndrome (FDA, 2013). This prodrug formula- a2d-1 subunit, enhancement of voltage-gated potassium tion is actively absorbed by the high capacity nutrient channels, and modulation of GABA activity (Sills, 2006). transporters, monocarboxylate transporters type 1 and The rationale underlying gabapentin as a treatment for sodium-dependent multivitamin transporters, located AUD is founded on preclinical evidence that G-IR reduced throughout the intestinal tract (Cundy et al., 2008). After alcohol intake in alcohol-dependent rats and normalized absorption, conversion to gabapentin takes place by non- stress-induced GABA activation in the extended amygdala specific esterases, primarily in enterocytes. One advantage of (Roberto et al., 2008), a stress-related brain region activated the prodrug, compared with G-IR, is a reduction in interpa- during early abstinence in alcohol dependence (Koob, 2008). tient variability in the blood levels and increased bioavail- Clinically, G-IR reduced symptoms of acute alcohol with- ability (Cundy et al., 2008). Furthermore, whereas G-IR is drawal (Myrick et al., 2009) and improved alcohol-induced taken 3 times per day, GE-XR only needs to be taken 2 times sleep disruption in a polysomnography study of normal par- per day, which may result in better treatment adherence, an ticipants (Bazil et al., 2005). In human laboratory studies, important aspect to consider when developing medications 1,200 mg/d of G-IR diminished symptoms of protracted for addiction (Weiss, 2004). abstinence, including craving and sleep disturbance (Mason The purpose of this study was to provide the first RCT et al., 2009), which have been identified as risk factors evaluation of the efficacy and safety of GE-XR as a treat- for relapse (Brower et al., 1998; Foster and Peters, 1999; ment for
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