Allergan Announces Results of Higher Dose BOTOX® Cosmetic (onabotulinumtoxinA) for the Treatment of Moderate to Severe Glabellar Lines

DUBLIN, Sept. 14, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced clinical study results of higher doses of BOTOX^® Cosmetic compared to BOTOX^® Cosmetic 20 unit dose at week 24 in patients with moderate to severe glabellar lines.

Allergan conducted this trial to evaluate the duration of effect and safety of BOTOX^® Cosmetic 40, 60, and 80 unit doses versus BOTOX^® Cosmetic 20 unit dose in patients with moderate to severe glabellar lines. The primary efficacy endpoint was met and was statistically significant for BOTOX^® Cosmetic 40 and 80 units versus 20 unit in 226 subjects at 24 weeks (analysis, ?1 point improvement in Facial Wrinkle Scale (FWS) from baseline assessed by Investigator at Maximum Frown). 

In this trial, 32% of patients were responders at week 24 in the BOTOX^® Cosmetic 40 unit group, 30.6% in the BOTOX^® Cosmetic 60 unit group, and 38.5% in the BOTOX^® Cosmetic 80 unit group as compared to 16% in the 20 unit group. The dose effect was observed across additional outcome variables. 

For responders with a > 1 point improvement, the time to return to baseline also demonstrated a dose-effect.  The median time on the Kaplan-Meier curve was 19.7 weeks for 20 Units and 24.0 weeks for 40 Units, suggesting the median benefit of 40 units is between 20 and 24 weeks.

"These study results help us better understand the BOTOX^® Cosmetic dose duration of effect and confirm our hypothesis that higher doses of botulinum toxin produce a longer duration of treatment effect for the treatment of glabellar lines," said David Nicholson, Chief Research and Development Officer, Allergan. "Based on this data, doubling the dose of botulinum toxin extends the duration of effect to 24 weeks in approximately one-third of patients." 

The higher doses of BOTOX^® Cosmetic were safe and well tolerated. In a total 233 patients evaluable for safety, there was one serious adverse event (SAE) unrelated to treatment. Overall treatment related adverse events (AEs) compare favorably with USPI labeled AEs and no new safety signals were identified.  Across all studied doses there was 1 case (0.4%) eyelid ptosis at 80 unit and 1 case (0.4%) eyebrow ptosis at 20 unit."

About Glabellar Lines

The Glabella is the skin between the eyebrows and above the nose. Glabellar Lines, often called "frown lines", are vertical lines that develop between the eyebrows and may appear as a single vertical line or as two or more lines and may also appear angled toward the inner corners of the eyebrows.  When we frown, the muscles of the lower forehead contract in a downward direction, causing the skin between the eyebrows to crease.  Lines are formed by the repeated action of frowning due to the lack of elasticity to the skin. Age, sun exposure, and genetics are contributing factors.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine 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, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.

Allergan's success is powered by our 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 on existing trends and information as of the date of this release. 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; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS^®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, debt reduction, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; 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, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

Approved Uses
BOTOX^® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.

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

• 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, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX^® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX^® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.

BOTOX^® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX^® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX^® Cosmetic if you: are allergic to any of the ingredients in BOTOX^® Cosmetic (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.

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

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX^® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX^® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX^® Cosmetic 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^® Cosmetic in the past.

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 (tell your doctor 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 aspirin-like products or blood thinners.

Other side effects of BOTOX^® Cosmetic 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 and eyebrows, swelling of your eyelids and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX^® Cosmetic full Product Information including Boxed Warning and Medication Guide.

SOURCE Allergan plc