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FDA Approves Botox to Treat Urinary Incontinence with MS

The U.S. Food and Drug Administration has approved Botox® (onabotulinum toxin A) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder. The approved treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence.

"Urinary incontinence associated with neurologic conditions can be difficult to manage,” said George Benson, deputy director, Division of Reproductive and Urologic Products. “Botox offers another treatment option for these patients."

Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder. Cystoscopy may require general anesthesia. The duration of the effect of Botox on urinary incontinence in people with bladder overactivity associated with a neurologic condition is up to 10 months.

The effectiveness of Botox to treat this type of incontinence was demonstrated in two clinical studies involving 691 patients. The participants had urinary incontinence resulting from spinal cord injury or MS. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo.

In addition to its use to improve the appearance of facial frown lines, Botox also is FDA-approved to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid, and a condition in which the eyes are not properly aligned.

The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder.

Botox is marketed in the United States by Allergan Inc., of Irvine, Calif. 

Laquinimod Faces Hurdles
Teva Pharmaceutical Industries, Ltd. faces growing challenges and uncertainty surrounding its MS treatments, according to an Oppenheimer analyst.

The Israeli drugmaker said that its experimental drug, laquinimod, an oral MS treatment, did not reduce patients' annual relapse rates in a late-stage clinical trial. The study involved 1,331 patients who were treated with one of three options: laquinimod, a placebo, or Avonex, an older MS drug made by Biogen Idec, Inc.

Teva said MRI scans showed the patients in the laquinimod and Avonex groups had more brain lesions, which indicates they had more severe multiple sclerosis, and if study results are adjusted to remove that imbalance, laquinimod met its main goal of lowering the relapse rate.

Teva and its partner Active Biotech still plan to seek approval of laquinimod in the U.S. and the European Union. In December, the companies said the drug met its main goal in its first late-stage trial.

Analyst Christopher Holterhoff said in a research note it is unclear whether the U.S. Food and Drug Administration will accept adjusted data from the latest study as meaningful or require Teva to run another study.

"We are unaware of a precedent case where an MS drug was approved without two statistically significant trials," the analyst wrote.

Free Smartphone App Helps Keep Track of Injections
A free smartphone app, TrackMyShots, is available to help ease the log-keeping of people with MS, diabetes, and other conditions requiring frequent injections.

The app eliminates the need for bulky log books by allowing the user to record each injection, track injection sites, and monitor adverse reactions. Users can set up an ongoing schedule for their injections and get email alerts when it is time for their next shot.

Developed by Linxter, Inc., a software development company in Cooper City, Fla., the app was created to help a family friend with MS, says company CEO and founder Jason Milgram.

“She had carried around a bulky paper logbook for years,” Milgram said. “She and her husband asked if I could help develop an app that would allow her to keep track of the injections.”

The app’s initial release is available for Windows Phone 7 users. An Android version was scheduled to be available in late August, and iPhone users will be able to access the app in late September.

TrackMyShots, http://trackmyshots.com, recently received a Hero of the Week award from Microsoft, which “honors excellence in the field of app development.”

Definitely going to look into that app!  It looks as though Gilenya may continue to be the only available oral treatment for awhile.