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FDA Approves Botox (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity

DUBLIN, Jan. 22, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. Botox is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity.

Botox was first approved for the treatment of upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers, in adults in March 2010. Additional FDA approval was received in April 2015 to expand the Botox label for the treatment of adults with ULS to include the addition of two thumb muscles. It is not known whether Botox is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or to treat increased stiffness in lower limb muscles other than those in the ankle and toes. Botox has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with Botox is not meant to replace your existing physical therapy or other rehabilitation that your doctor may have prescribed.

"Spasticity is a debilitating condition that can have a significant impact on patients' lives, compromising their ability to perform a range of daily activities," said Mitchell F. Brin, M.D., Senior Vice President Global Development and Scientific Officer, Botox. "This FDA approval marks our continued commitment to partnering with scientists and researchers around the world to explore the potential benefits of Botox in treating specific medical conditions. We are pleased that through this research, we are now able to offer this treatment option for patients with lower limb spasticity."

Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness of muscle, which may interfere with movement, or be associated with discomfort.[i] Affecting approximately 1 million people in the U.S., spasticity is usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement.[ii] The most common causes of spasticity include stroke, adult cerebral palsy, multiple sclerosis, traumatic brain injury, spinal cord injury, physical trauma, or infection.[ii]

"In my experience, stroke survivors are among the most prominent groups to be impacted by spasticity affecting the upper and lower limbs; and it is critical to continue seeking treatment from a physician specially trained to manage spasticity," said Alberto Esquenazi, M.D., John Otto Haas Chair and Professor, Department of Physical Medicine and Rehabilitation; Director, Gait & Motion Analysis Laboratory, MossRehab, and a lead investigator in the studies. "The results reinforce the efficacy and safety of Botox, and physicians can now have even greater confidence when offering their patients another approach to treating these specific muscles."

The FDA approval was based on a large, international development program that included a phase three, multi-center, double-blind, randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of BOTOX® compared to placebo in more than 400 patients with lower limb spasticity following stroke. The study compared a total Botox dose of 300 to 400 units divided among ankle and toe muscles (n=233) to placebo (n=235). Statistically significant improvements were observed in the two co-primary endpoints of average change from baseline in the improvement of muscle tone measured by the Modified Ashworth Scale (MAS) ankle score and the clinical benefit for patients as assessed by the Clinical Global Impression of Change by Physician (CGI) at weeks 4 and 6 (p<0.05). The most frequently reported adverse reactions (>2%) were arthralgia (3%), back pain (3%), myalgia (2%), upper respiratory tract infection (2%) and injection site pain (2%). The safety profile observed in the study was consistent with the known safety profile of Botox.

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

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.

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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 (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.

[i] NINDS Spasticity Information Page. National Institute of Neurological Disorders and Stroke. Available at ttp://www.ninds.nih.gov/disor.... Accessed November 23, 2015
[ii] Data on File, Allergan, Inc. Global Safety and Epidemiology: Spasticity and comorbidity following five disorders: stroke, multiple sclerosis, spinal cord injury, traumatic brain injury, and cerebral palsy in adults, 2009.

SOURCE Allergan plc

Posted: January 2016

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