Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Antares Pharma, a specialty pharmaceutical company, has submitted a new drug application (NDA) for Anturol Gel with the US Food and Drug Administration (FDA) as a treatment for the patients with overactive bladder (OAB).
Subscribe to our email newsletter
Antares Pharma said that the NDA filing was supported by a Phase 3 clinical trial, which demonstrated a reduction in urinary incontinence episodes for both doses studied (56mg daily or 84mg daily).
The trial was conducted under a special protocol assessment (SPA) with the FDA.
In addition, an Open Label Extension study, evaluating long-term safety has been successfully completed.
Antares Pharma president and CEO Paul Wotton said that the NDA submission for Anturol represents a significant accomplishment for the company in 2010.
"The dedicated efforts of the Antares team allowed us to achieve our goal of submitting the NDA prior to year end and we are pleased with this achievement," Wotton said.