FDA's Nonprescription Drugs Advisory Committee to meet on Oxytrol Rx-to-OTC switch

SILVER SPRING, Md. — According to a Food and Drug Administration post Friday, the FDA's Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system) submitted by MSD Consumer. The proposed OTC product would be called Oxytrol for Women and would be indicated for the treatment of overactive bladder in women.

The prescription form of Oxytrol is licensed by Watson Pharma.

The data to be discussed will include a summary of the postmarketing experience with the oxybutynin transdermal system, and the results of consumer studies, including label comprehension studies, self-selection studies and an actual use study. The committee will be asked to consider whether the data support the appropriate and safe use of oxybutynin transdermal system by OTC consumers.

According to the U.S. National Library of Medicine, oxybutynin transdermal patches are used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate and inability to control urination). Oxybutynin is in a class of medications called anticholinergics. It works by relaxing the bladder muscles to prevent urgent, frequent or uncontrolled urination.

About 17% of women over the age of 18 experience overactive bladder, according to the National Association for Continence. In women between the ages of 20 and 45, the prevalence of overactive bladder was found to be 36.8%.

Overactive bladder occurs about twice as frequently in women as in men and become more prevalent with advanced aging.

"Women with [overactive bladder] are significantly more likely to suffer from other health disorders, such as hypertension, obesity and arthritis, than women without OAB," the NAC added. "Also, [overactive bladder] sufferers are two to three times more likely to regularly experience disturbed sleep, overeating and poor self-esteem, compared with non-OAB sufferers."


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