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Allergan Announces Positive Top-Line Results From Phase III BOTOX® Overactive Bladder Program

Stocks in this article: AGN

Allergan, Inc. (NYSE: AGN) today announced that two Phase III clinical trials of BOTOX ® (onabotulinumtoxinA) as a potential treatment option for patients with idiopathic overactive bladder met their pre-specified primary endpoints. Results from both Phase III clinical trials demonstrate that BOTOX ® significantly reduced urinary incontinence (bladder leakage) episodes compared to placebo for the treatment of overactive bladder patients with urinary incontinence who were not adequately managed by an anticholinergic treatment. The summary data are being presented as part of Allergan’s Research and Development Technology Review, which will be held today at 1 p.m. Eastern Time. The full study results of the North American Phase III study are expected to be presented at an upcoming medical meeting.

Based on the results of the two Phase III clinical trials, Allergan has submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) and an application with European Regulatory authorities seeking approval for the use of BOTOX ® as treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. BOTOX ® is currently approved in the United States and in several European countries for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

“Allergan is committed to the research and clinical development of novel treatment options for urologists and their patients, and we look forward to potentially expanding the use of BOTOX ® as a treatment option following approval by the respective regulatory agencies,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development, Chief Scientific Officer. “We are pleased with the results of our idiopathic overactive bladder Phase III clinical trials, which demonstrated that BOTOX ® treatment provided benefit to these overactive bladder patients with symptoms of urinary incontinence who failed or were intolerant of other therapy.”

Overactive bladder (OAB) is a medical condition that results in an uncontrolled urge to void, frequent voids and, in many patients, uncontrolled urinary leakages. In most cases, the precise cause of OAB is unknown. An estimated 13 million adults in the United States experience urinary incontinence, or bladder leakage, as a symptom of OAB. An estimated 3.2 million Americans with OAB, with or without urinary incontinence, are taking oral medications known as anticholinergics, which is the current standard of care. 1 It is estimated, however, that greater than 50 percent of these patients discontinue oral medications, likely due to an inadequate response to, or intolerance of, the medication. 2,3,4

Both Phase III clinical trials included patients with symptoms of OAB not caused by a neurological condition who were suffering with urinary incontinence for at least six months and who were inadequately treated with an anticholinergic therapy. Patients were randomly assigned to treatment with BOTOX ® or placebo injections into the detrusor (bladder) muscle, followed by an injection with BOTOX ® after a minimum of 12 weeks if desired. In both studies, there was a highly statistically significant decrease in the number of daily incontinence episodes in patients treated with BOTOX ® vs. placebo (p<0.001).

In both Phase III clinical trials, BOTOX ® treatments were well tolerated in patients suffering from OAB symptoms with urinary incontinence. Adverse events were primarily limited to the urinary tract, with urinary tract infection rates between 15-20 percent and urinary retention rates between 5-6 percent for patients treated with BOTOX ® in both studies. Patients receiving BOTOX ® treatments in both studies also reported an improvement in quality of life.

About BOTOX ® (onabotulinumtoxinA)

BOTOX ® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. BOTOX ® has a unique, protected molecular structure that stabilizes the core toxin in BOTOX ® from degradation. When injected at FDA-approved and labeled doses into a specific muscle or gland, BOTOX ® neurotoxin is expected to diffuse locally and produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately three to ten months depending on the indication and on the individual patient.

BOTOX ® was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval in 1989, BOTOX ® has been recognized by regulatory authorities worldwide as an effective treatment for 25 different indications in approximately 85 countries, benefiting millions of patients worldwide. In the United States, BOTOX ® neurotoxin is also approved to treat seven medical conditions, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; and most recently, for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury (SCI), multiple sclerosis (MS)) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

In addition to its therapeutic uses, the same formulation of BOTOX ® with dosing specific to moderate to severe glabellar lines was approved by the FDA in 2002 under the trade name BOTOX ® Cosmetic (onabotulinumtoxinA). BOTOX ® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) associated with corrugator and/or procerus muscle activity in adult patients up to 65 years of age.

In addition to approximately 21 years of clinical experience, the safety and efficacy of BOTOX ® have been well-established in approximately 65 randomized, placebo-controlled clinical trials and in approximately 15,000 patients treated with BOTOX ® and BOTOX ® Cosmetic in Allergan’s clinical trials. 5 Worldwide, approximately 30 million vials of BOTOX ® and BOTOX ® Cosmetic have been distributed and approximately 29 million treatment sessions have been performed over the past 20 years (1990-2010). 6 With approximately 2,500 articles on BOTOX ® and BOTOX ® Cosmetic in scientific and medical journals, 7 BOTOX ® neurotoxin is one of the most widely researched medicines in the world.

BOTOX ® (onabotulinumtoxinA) & BOTOX ® Cosmetic (onabotulinumtoxinA) Important Information

IndicationsBOTOX ® is a prescription medicine that is injected into muscles and used:

  • 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
  • to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
  • to treat increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity
  • to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
  • to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older

BOTOX ® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

It is not known whether BOTOX ® and BOTOX ® Cosmetic is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

It is not known whether BOTOX ® and BOTOX ® Cosmetic 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 your existing physical therapy or other rehabilitation that your doctor may have prescribed.

It is not known whether BOTOX ® and BOTOX ® Cosmetic are safe or effective for severe sweating anywhere other than your armpits.

IMPORTANT SAFETY INFORMATION BOTOX ® and BOTOX ® Cosmetic 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 ® or 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 (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.

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX ® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines.

Do not take BOTOX ® or BOTOX ® Cosmetic 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.

The dose of BOTOX ® and BOTOX ® Cosmetic 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 ® or BOTOX ® Cosmetic 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 ® or BOTOX ® Cosmetic.

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 or 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 ®.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX ® for their blepharospasm, especially in people with certain nerve disorders. BOTOX ® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX ®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX ® for their strabismus. Tell your doctor if you notice any new visual problems while 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.

Autonomic Dysreflexia and Urinary Retention in Patients Treated for Detrusor Overactivity Associated With a Neurologic ConditionAutonomic 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).

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.

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