Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the US Food and Drug Administration (FDA). Watson is seeking marketing approval of this novel transdermal gel of oxybutynin hydrochloride for the treatment of overactive bladder (OAB).
OTG is a clear, rapid-drying gel designed to produce consistent oxybutynin concentrations over a 24-hour period. By administering oxybutynin through the skin, OTG avoids first pass metabolism and the resultant high metabolite levels seen with oral oxybutynin dosing. A nickel-sized, one-gram unit dose of OTG, applied once daily, delivers about 4mg oxybutynin each day.
OTG is a clear, odorless, ethanolic gel that provides for delivery of oxybutynin hydrochloride in a non-patch transdermal form. OTG is under development for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
"Innovative products like OTG represent Watson's ongoing focus on developing effective, safe and convenient treatments that help to improve patients' lives," said Ed Heimers, jr., executive vice president and president of Watson's Brand Division. "We believe this new formulation of oxybutynin signifies an important advancement in treatment options for OAB as it offers the benefits of transdermal therapy with excellent skin tolerability."
The NDA filing for OTG is based on data from a phase 3 randomized, double-blind, placebo-controlled study involving 789 patients with OAB. In the 12-week study, patients treated with OTG once daily experienced a highly significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per day, a decrease in urinary frequency and an increase in the average urine volume per void. Significant improvements relative to placebo in quality of life, as measured by the Incontinence Impact Questionnaire (IIQ) and the incontinent specific domains of the King's Health Questionnaire (KHQ), were also observed in the patients using the OTG.
OTG was well tolerated in the study and there were no serious adverse events related to treatment. Dry mouth and application site pruritus were the only treatment-related side effects reported in more than 2% of participants.
"Watson is excited to be expanding the portfolio of innovative treatments it offers physicians and their patients," Heimers said. "Through developing novel therapies such as the OTG, we can continue to be the partner of choice to help the millions of people suffering from urological conditions manage their symptoms and enjoy their daily lives."