Merck wins OTC switch for OAB drug Oxytrol for US women; men still need Rx
This article was originally published in Scrip
The US FDA granted its blessing to Merck on 25 January to switch its overactive bladder medicine Oxytrol (oxybutynin transdermal system, 3.9 mg/day) from a prescription product to over-the-counter (OTC) for use in women.
The FDA considers the move a partial switch, however, because men with OAB can only obtain Oxytrol with a prescription.
But as an OTC medicine for women, Oxytrol offers those patients an option to "independently manage their condition and achieve a newfound sense of control," said Dr Eman Elkadry of Boston Urogynecology Associates at Mount Auburn Hospital and a clinical instructor at Harvard Medical School. "The approval also provides recognition that this is a real medical disorder that can be addressed."
OAB affects more than 20 million American women, more than 80% of whom do not seek treatment, according to Merck
The condition, which generally strikes between the ages of 45 and 60 years, is characterized by a strong urge to urinate right away and more often than usual, with or without leakage.