Actavis Announces FDA Approval of Expanded Label for BOTOX® (OnabotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Adults

DUBLIN, April 20, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT), which recently completed the acquisition of Allergan, today announced that the United States Food and Drug Administration (FDA) has approved an expansion of the BOTOX^® (onabotulinumtoxinA) label for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity. The FDA also approved an increase to the maximum BOTOX^® cumulative dose within three months from 360 to 400 units in adults treated for one or more indications. 

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BOTOX® is the first and only neurotoxin approved by the FDA for the treatment of upper limb spasticity—a debilitating neurological condition, producing muscle stiffness that can result in tight muscles in the elbow, wrist and fingers including thumb.¹ This FDA approval expands the therapy's previous approval in 2010. In patients 18 years and older with upper limb spasticity, BOTOX®, a prescription medicine, is injected into muscles and used to treat increased muscle stiffness in elbow, wrist and finger 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 and fingers, or to treat increased stiffness in lower limb muscles. 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 existing physical therapy or other rehabilitation prescribed by a doctor.

"It's critical for patients who suspect they may be experiencing upper limb spasticity in the elbow, wrist and fingers including thumb to seek a consultation with a physician specifically trained to treat upper limb spasticity, such as a neurologist or physical medicine and rehabilitation (PM&R) specialist. Often, even if the person has been suffering with the condition for years, there are ways to manage upper limb spasticity effectively," said Mitchell F. Brin, M.D., Senior Vice President Global Development and Chief Scientific Officer, BOTOX®. "The FDA approval of the expanded BOTOX® indication for upper limb spasticity represents the Company's ongoing commitment to research and development in areas of unmet need. BOTOX® continues to provide effective patient care across a broad spectrum of medical conditions." 

More than 1.8 million Americans live with upper limb spasticity, which can occur weeks, months or even years after a stroke.²  The condition can manifest after a patient has stopped seeing a specialist for follow-up care. 

"Simple tasks such as washing the affected hand or getting dressed can be limiting for patients with the condition, and they're often left to depend on a caregiver to help them," said lead clinical trial investigator Allison Brashear, M.D., Professor and Chair, Department of Neurology at Wake Forest Baptist Medical Center in Winston-Salem, NC. "It's important for patients experiencing these types of symptoms to talk to their doctor who can refer them to a neurologist or physiatrist to discuss their treatment options."

This expanded label approval for the two thumb flexor muscles is based on two additional randomized, multi-center, double-blind, placebo-controlled studies evaluating the efficacy and safety of BOTOX® in patients with upper limb spasticity. 

In the first study, the efficacy and safety of one-time BOTOX® injections in 170 patients with upper limb spasticity were evaluated. Patients received a single treatment of BOTOX® (40 units) or placebo into thumb flexor muscles. This study investigated the median change from baseline to week 6 in thumb flexor tone measured by the modified Ashworth Scale. Results showed that BOTOX® neurotoxin produced a clinically and statistically significant reduction of 1.0 BOTOX® vs 0.0 placebo (p< 0.001).

The second trial evaluated the efficacy and safety of one-time BOTOX® injections in 109 patients with upper limb spasticity. Patients received a single treatment with lower dose (30 units) or higher dose (40 units) of BOTOX® or placebo into thumb flexor muscles. The study found that the higher dose of BOTOX® produced a clinically and statistically significant reduction in thumb flexor muscle tone on the modified Ashworth Scale of 0.5 BOTOX® vs 0.0 placebo (p< 0.010).

The most frequently reported adverse reactions following injection of BOTOX® for upper limb spasticity include pain in extremity, muscle weakness, fatigue, nausea and bronchitis.

BOTOX® (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION
BOTOX^® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX^®:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities

Do not take BOTOX^® if you: are allergic to any of the ingredients in BOTOX^® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc^® (rimabotulinumtoxinB), Dysport^® (abobotulinumtoxinA), or Xeomin^® (incobotulinumtoxinA); have a skin infection at the planned injection site.

The dose of BOTOX^® is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX^® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX^®.

Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX^® for upper limb spasticity. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX^®.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX^® for their upper limb spasticity. Upper respiratory infections (common colds) were also reported more frequently in people with prior breathing-related problems.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX^® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX^® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX^® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX^® in the past.

Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc^®, Dysport^®, or Xeomin^® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).

Other side effects of BOTOX^® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.  Please see BOTOX^® full Product Information including Boxed Warning and Medication Guide.

® marks owned by Actavis plc.
Myobloc® is a registered trademark of Solstice Neuroscience, Inc.
Dysport® is a registered trademark of Ipsen Biopharm, Ltd.
Xeomin® is a registered trademark of Merz Pharma Gmbh & Co.

About Actavis

Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Actavis 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.

Actavis markets a portfolio of best-in-class products that provide valuable treatments for the women's health, central nervous system, eye care, medical aesthetics, gastroenterology, 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. Actavis 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, Actavis 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.

Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.

For more information, visit Actavis' website at www.actavis.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 Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' 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 Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

¹ Mayer NH and Esquenazi A. Muscle overactivity and movement dysfunction in the upper motoneuron syndrome.  Phys Med Rehabil Clin N Am 2003;14:855-883.

² Wissel J, Schelosky LD, Scott J, Christe W, Faiss JH, Mueller J. Early development of spasticity following stroke: a prospective, observational trial. J Neurol. 2010;257:1067-1072.

CONTACTS:

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SOURCE Actavis plc

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