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Drug Development

IND filed for gel to treat overactive bladder syndrome

Published in Women's Health Weekly, April 14th, 2005

Antares Pharma, Inc., (AIS) filed an Investigational New Drug (IND) application on March 14, 2005, for the company's first proprietary pharmaceutical product (AP-1034), oxybutynin ATD gel for overactive bladder syndrome (OAB).

Based on the evidence provided by the company in its pre-IND meeting with the FDA, the company was granted the right to proceed directly into a phase II dose ranging study upon concurrence with the protocol submitted, as well as conduct only a single phase III study.

Jack E. Stover, president and CEO of Antares Pharma, commented, "The submission of Antares Pharma's first proprietary pharmaceutical submission to the FDA is an...

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