"DUBLIN April   PRNewswire  Allergan plc NYSE AGN a leading global pharmaceutical company today announced topline data from a Phase II study with Major Depressive Disorder MDD. The study evaluated the efficacy safety and tolerability of a single administration of  different doses of BOTOX  units or  units relative to placebo in adult females with MDD over duration of up to  weeks.   The BOTOX  U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo. The treatment LS mean difference for  U was . at  weeks p value . . at week  pvalue . and . at week  pvalue .. The primary end point was at week . The  U did not demonstrate superior efficacy over placebo LS mean difference was .. Both secondary efficacy variables CGIS and HAMD showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for  U but not for  U. Both  U and  U were well tolerated. We are encouraged by these data and the potential impact on adults with major depressive disorder. Given our indepth and extensive clinical trial experience in CNS including depression we plan to move forward and develop a phase  program for  a potential new treatment option for patients said David Nicholson Chief Research and Development Officer Allergan. Study Design   This study was a proof of concept Phase II multicenter randomized doubleblind placebocontrolled dose cohort parallel group single treatment study in adults females with moderate to severe Major Depressive Disorder MDD.  patients with a minimum total score of  on the Hamilton Rating Scale for Depression and a score of  on the Clinical Global Impressions Scale were randomized   into three groups receiving either BOTOX  U BOTOX  U or placebo. As the number of injections differed between the  U and the  U group each study site was randomly assigned to only one of the doses and matching placebo.  The study took place over  weeks with a  week screening period and up to  weeks post DB treatment. The primary endpoint of the study was change from baseline to week  in MontgomeryAsberg Depression Rating Scale MADRS total score for BOTOX  U vs. placebo and BOTOX  U vs. placebo and combined BOTOX  U and  U vs. combined placebo groups. About Allergan  Allergan plc NYSE AGN headquartered in Dublin Ireland is a bold global pharmaceutical company.  Allergan is focused on developing manufacturing and commercializing branded pharmaceuticals devices and biologic products for patients around the world. Allergan markets a portfolio of leading brands and bestinclass products for the central nervous system eye care medical aesthetics and dermatology gastroenterology womens health urology and antiinfective therapeutic categories. Allergan is an industry leader in Open Science the Companys RD model which defines our approach to identifying and developing gamechanging ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with  midtolate stage pipeline programs in development. Our Companys success is powered by our more than  global colleagues commitment to being Bold for Life. Together we build bridges power ideas act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately  countries Allergan is committed to working with physicians healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer healthier lives every day. For more information visit Allergans website at  http ForwardLooking Statement  Statements contained in this press release that refer to future events or other nonhistorical facts are forwardlooking statements that reflect Allergans current perspective of existing trends and information as of the date of this release. Except as expressly required by law Allergan disclaims any intent or obligation to update these forwardlooking statements. Actual results may differ materially from Allergans current expectations depending upon a number of factors affecting Allergans business. These factors include among others the difficulty of predicting the timing or outcome of FDA approvals or actions if any the impact of competitive products and pricing market acceptance of and continued demand for Allergans products difficulties or delays in manufacturing and other risks and uncertainties detailed in Allergans periodic public filings with the Securities and Exchange Commission including but not limited to Allergans Annual Report on Form K for the year ended December   and Quarterly Report on Form Q for the quarter ended September   certain of such periodic public filings having been filed under the Actavis plc name. Except as expressly required by law Allergan disclaims any intent or obligation to update these forwardlooking statements. CONTACTS  Investors Karina Calzadilla   Media  Mark Marmur     To view the original version on PR Newswire visithttp http SOURCE Allergan plc Print this page javascriptwindow.print Share on Facebook https Share on Twitter httptwitter.comhomestatusAllerganReportsToplinePhaseIIDataSupportingAdvancementofBOTOXonabotulinumtoxinAforthehttps Share on Google httpsplus.google.comshareurlhttps Share on LinkedIn http View our RSS Feed https"