Reuters (1/26, Berkrot) reported that the US Food and Drug Administration on Friday announced it has approved an over-the-counter version of Merck's Oxytrol (oxybutynin) as a treatment for overactive bladder in women ages 18 years and older. The agency noted that findings from nine trials involving 5,000 study participants, showed that consumers readily understand information on the drug-product's labeling and that they are able to use oxybutynin appropriately. The Whitehouse Station, New Jersey-based pharmaceutical company said it expects to launch the OTC version on the market in the fall. However, the FDA said that for men with overactive bladder, only the prescription version of Oxytrol will be available.
According to MedPage Today (1/26, Gever), Merck "did not seek OTC status for the product in men." The nine studies showed that men were "relatively poor at correctly determining whether oxybutynin was the appropriate treatment for their urination problems. A key worry is that incorrect self-diagnosis in men could delay detection of prostate cancer."
The Triangle Business Journal (1/26, Ohnesorge, Subscription Publication) noted that the FDA's approval made Oxytrol the first, overactive bladder treatment in the anticholinergics class to become available OTC. Oxytrol is a "patch applied to the skin every four days."
WebMD (1/26, Doheny) also covered the story, noting that according to Merck, "more than 20 million American women" have overactive bladders.
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