Allergan Announces New Long-Term OnabotulinumtoxinA Treatment Study Results at the American Urogynecologic Society Meeting

DUBLIN, Oct. 15, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that results from an extension study of two phase 3 trials showed that long-term onabotulinumtoxinA treatment consistently decreased urinary incontinence in female patients with overactive bladder (OAB) symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication. Final results were presented in a podium session at the American Urogynecologic Society Meeting. 

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Findings were based on a multicenter, 3.5-year extension study assessing the long-term safety and efficacy of onabotulinumtoxinA treatment in 749 female patients with OAB. Patients who completed either of two 24-week, phase 3 trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 units) treatments. Of the 749 female patients enrolled, more than half (53%) completed the study. Discontinuations due to adverse events or lack of efficacy were low (4.8/5.3%); other reasons were not treatment-related.

Data were analyzed for the overall population of patients and within discrete subgroups of patients who received exactly 1, 2, 3, 4, 5, or 6 treatments of the 100U dose throughout the study. Mean reductions from baseline in urinary incontinence episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups of female patients who received 1 to 6 treatments. A consistently high proportion of patients reported improvement or great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (69.6-100%). Incontinence Quality of Life scores were consistently >2.5 times the minimal important difference (+10 points). The overall median duration of effect was 8 months (38.4% >6 to <12 months). The most common adverse event was urinary tract infection, with no changes in safety profile over time.

"Results of this extensive 3.5-year study demonstrates consistent safety and efficacy of long-term onabotulinumtoxinA treatment in this population of female overactive bladder patients," said Peter Sand, M.D., urogynecologist and clinical professor, North Shore University Health System, University of Chicago. "These findings may help inform specialists treating patients with overactive bladder, that BOTOX is an effective and safe treatment option for patients not getting the relief from an anticholinergic." 

Overactive Bladder

OAB is a condition where the bladder contracts uncontrollably, creating leakage, the strong sudden need to "go right away," and going too often. It's important to realize that OAB is not a "weak" bladder. In fact, OAB occurs when nerves are affected. These nerves send signals to your bladder at the wrong time, causing the muscle to squeeze without warning. This process causes your bladder to spasm uncontrollably, creating leakage, the strong sudden need to "go," and going too often. BOTOX® is approved to treat overactive bladder symptoms, such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken.

BOTOX® (onabotulinumtoxinA) Important Information

Indications

BOTOX® is a prescription medicine that is injected into the bladder muscle and used:

• to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.
• to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication.

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.

Do not take BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.

Patients treated for overactive bladder

In clinical trials, 36 of the 552 patients had to self-cathetherize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo. Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.

Patients treated for overactive bladder due to neurologic disease

In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n=33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n=7).

Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.

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 detrusor overactivity associated with a neurologic condition. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX®.

Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).

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; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; 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 anticoagulants (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. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

For more information refer to the Medication Guide or talk with your doctor. To report a side effect, please call Allergan at 1-800-433-8871. Please see BOTOX® full Product Information including Boxed Warning and Medication Guide.

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 risks associated with acquisition transactions; 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 March 31, 2015 (such periodic public filings having been filed under the "Actavis plc" name) and from time to time in Allergan's other investor communications. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:     
Investors:
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Media:
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SOURCE Allergan plc

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