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news.The US food and drug administration (FDA) has accepted Antares Pharma’s Anturol Gel new drug application (NDA) for review.
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Anturol Gel, an oxybutynin gel incorporating Antares’ advanced transdermal delivery (ATD) Gel technology, is indicated for treatment in patients with overactive bladder (OAB).
FDA is expected to complete the NDA review by 8 December 2011 as per the Prescription Drug User Fee Act (PDUFA) date assigned.
Anturol’s NDA submission is supported by phase 3 clinical trial data involving 600 patients with OAB.
OAB patients treated with the 56mg daily or 84mg daily showed a significant decrease in the symptoms compared to placebo including the urinary incontinence episodes per day.
Antares Pharma claimed by delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided leading to lower anticholinergic side effects compared to orally administered treatments.