OTC oxybutynin for overactive bladder in women
In January 2013, FDA approved the first OTC treatment for overactive bladder in women. The oxybutynin transdermal system is identical to the prescription product Oxytrol and will be marketed as Oxytrol for Women by Merck Consumer Care. Merck expects the product to be available in fall 2013. Oxytrol for the treatment of overactive bladder symptoms in men will remain a prescription-only product.1
Overactive bladder is defined by the International Continence Society as the presence of urinary urgency, usually with frequency and nocturia, with or without urgency incontinence, in the absence of infection or other urinary tract disorders.2 The estimated prevalence of overactive bladder is between 16% and 43%.3 More than 20 million U.S. women are affected by overactive bladder.4
The consequences of overactive bladder symptoms are substantial. Patients with overactive bladder report lower overall quality of life, higher levels of depression, less sexual satisfaction, poorer sleep quality, and lower work productivity compared with patients without the condition.3 Sufferers of overactive bladder also may experience dehydration and hypotension when they attempt to minimize their symptoms by restricting fluid intake. Finally, skin irritation and ulceration can occur if patients are exposed to soiled clothing for prolonged periods of time.5
One of the challenges that the manufacturer had to overcome during the FDA approval process was to demonstrate that women are able to distinguish overactive bladder symptoms from those of other types of urinary incontinence (e.g., stress, mixed incontinence). The results of nine studies involving more than 5,000 participants were sufficient for FDA to conclude that patients can understand the information on the label, determine whether the product is right for them, and use the product appropriately.1
Oxytrol for Women is a patch that is applied to the skin of the abdomen, hips, or buttocks every 4 days. The patches can be worn during all activities of everyday living, including bathing and exercise. Each patch delivers oxybutynin 3.9 mg daily for 4 days. Oxybutynin is an anticholinergic that relaxes the detrusor muscle in the bladder, thereby reducing urinary urgency, frequency, and incontinence.
According to the proposed package labeling, Oxytrol for Women is indicated for the treatment of overactive bladder in women 18 years or older with two or more of the following symptoms:
- The need to urinate more than eight times in 24 hours
- A strong need to urinate right away
- An inability to control the urge to urinate that causes leaking or wetting
The most common adverse effects reported during the clinical trials were mild local irritation, dry mouth, and constipation.6
- Food and Drug Administration. FDA approves over-the-counter Oxytrol for Women to treat overactive bladder. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336815.htm?source…. Accessed July 3, 2013.
- Haylen BT, de Ridder D, Freeman RM, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5–26.
- Bartley JM, Blum ES, Sirls LT, Peters KM. Understanding clinic options for overactive bladder [published online ahead of print June 30, 2013]. Curr Urol Rep.
- National Association for Continence. New survey finds women with OAB symptoms are not diagnosed. www.nafc.org/news/188/521/New-Survey-Finds-Women-with-OAB-Symptoms-Are-…. Accessed July 3, 2013.
- O’Neil CK. Adult urinary incontinence and supplies. In Krinsky DL, Berardi RR, Ferreri SP, et al., Eds. Handbook of nonprescription drugs: an interactive approach to self care. 17th ed. Washington, DC: American Pharmacists Association; 2012:937–51.
- Watson Pharmaceuticals. Oxytrol for Women: FAQ. www.oxytrol.com/p/about_faq.asp. Accessed July 3, 2013.