Allergan Reports Topline Phase II Data Supporting Advancement of BOTOX® (onabotulinumtoxinA) for the Treatment of Major Depressive Disorder (MDD)
DUBLIN, April 5, 2017 /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 2 different doses of BOTOX® (30 units or 50 units) relative to placebo in adult females with MDD over duration of up to 24 weeks.
The BOTOX® 30 U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo. The treatment (LS mean) difference for 30 U was -4.2 at 3 weeks (p- value 0.005); -3.7 at week 6 (p-value 0.053) and -3.6 at week 9 (p-value 0.049). The primary end point was at week 6. The 50 U did not demonstrate superior efficacy over placebo (LS mean difference was 1.3). Both secondary efficacy variables (CGI-S and HAMD-17) showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for 30 U, but not for 50 U. Both 30 U and 50 U were well tolerated.
“We are encouraged by these data and the potential impact on adults with major depressive disorder. Given our in-depth and extensive clinical trial experience in CNS including depression, we plan to move forward and develop a phase 3 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, multi-center, randomized, double-blind, placebo-controlled, 2-dose cohort parallel group, single treatment study in adults females with moderate to severe Major Depressive Disorder (MDD). 258 patients (with a minimum total score of 18 on the Hamilton Rating Scale for Depression and a score of 4 on the Clinical Global Impressions Scale) were randomized (1:1:2) into three groups receiving either BOTOX® 30 U, BOTOX® 50 U or placebo. As the number of injections differed between the 30 U and the 50 U group, each study site was randomly assigned to only one of the doses and matching placebo. The study took place over 26 weeks with a 2 week screening period and up to 24 weeks post DB treatment. The primary endpoint of the study was change from baseline to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score for BOTOX® 30 U vs. placebo and BOTOX® 50 U vs. placebo; and combined BOTOX® 30 U and 50 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 best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing 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 70+ mid-to-late stage pipeline programs in development.
Our Company’s success is powered by our more than 16,000 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 100 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 Allergan’s website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s 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 forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s 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 Allergan’s products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (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 forward-looking statements.
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