Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials

September 2018 | Volume 17 | Issue 9 | Original Article | 987 | Copyright © September 2018


Angela Moore MD,a Lawrence J. Green MD,b Suzanne Bruce MD,c Neil Sadick MD,d Eduardo Tschen MD MBA,e Philip Werschler MD FAAD FAACS,f Fran E. Cook-Bolden, MD,g Sunil S. Dhawan MD,h Douglass Forsha MD,i Michael H. Gold MD FAAD,j Scott Guenthner MD,k Steven E. Kempers MD,l Leon H. Kircik MD,m Jennifer L. Parish MD,n Marta I. Rendon MD,o Phoebe Rich MD,p Linda Stein-Gold MD,q Stephen K. Tyring MD PhD,r Robert A. Weiss MD FAAD,s Adnan Nasir MD,t Carsten Schmitz MD PhD,u* Terry I. Boodhoo MS,u Alexandre Kaoukhov MD,u,* and David R. Berk MDu

aArlington Research Center, Inc., Arlington, TX bLawrence J. Green, MD, LLC, George Washington University School of Medicine, Washington, DC cSuzanne Bruce and Associates, PA, Houston, TX dSadick Research Group, New York, NY eAcademic Dermatology Associates, Albuquerque, NM fPremier Clinical Research, Spokane, WA gSkin Specialty Dermatology, New York, NY hCenter for Dermatology Clinical Research, Inc, Fremont, CA iJordan Valley Dermatology Center, Jordan, UT jTennessee Clinical Research Center, Nashville, TN kThe Dermatology Center of Indiana, PC, Plainfield, IN lAssociated Skin Care Specialists, Fridley, MN mDermResearch, PLLC, Louisville, KY nParish Dermatology, Philadelphia, PA oRendon Center, Boca Raton, FL pOregon Dermatology and Research Center, Portland, OR qHenry Ford Health System, West Bloomfield, MI rUniversity of Texas Health Science Center, Department of Dermatology, Houston, TX sLaser Skin & Vein Institute, Hunt Valley, MD tWake Research Associates, Raleigh, NC uAllergan plc, Irvine, CA *Former employee

explanation may be that sarecycline exerts anti-inflammatory effects on an early inflammatory process that is postulated to occur during the development of comedones.11,12 Antibiotic resistance is a concern with oral antibiotic treatments for acne.3-7 Agents that unnecessarily target a broad spectrum of bacteria are associated with greater potential for antibiotic resistance,13 and the American Academy of Dermatology recommends responsible usage of systemic antibiotics for acne.1 The current first-line antibiotics for moderate to severe acne are broad-spectrum tetracycline-class antibiotics, such as minocycline and doxycycline,1 highlighting the need for a narrow-spectrum antibiotic that can be used as first-line treatment for moderate to severe acne. In vitro studies have demonstrated the narrow antibacterial spectrum of sarecycline and its limited activity against enteric gram-negative bacteria (Data on file; Allergan plc, Dublin, Ireland).The antibacterial profile of sarecycline, particularly its targeted activity against P. acnes, may reduce its potential for disrupting the human gut microbiome. In contrast, administration of the tetracycline-class antibiotics doxycycline, minocycline, and tetracycline has been associated with disruption of the gut microbiome.14-16 The favorable safety profile of sarecycline in these studies represents an important finding for a tetracycline-class antibiotic. Tetracycline-class antibiotics may be associated with GI side effects and phototoxicity (typically seen with doxycycline) or vestibular side effects (observed with minocycline),3 yet low rates of such side effects were reported in these studies with sarecycline. In the current phase 3 studies, the incidence of AEs related to the GI tract, including nausea, vomiting, diarrhea, and abdominal pain, was low.