Antares Pharma Inc., a specialty pharmaceutical company that develops and licenses drug delivery technology for next-generation lifestyle products, has announced that it filed an Investigational New Drug (IND) application on Monday, 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 important milestone in our specialty pharma strategy.” Mr. Stover added, “It is especially rewarding to have been granted the right to proceed expeditiously with our clinical studies. We believe this accomplishment is indicative of our ability to execute on our commercial plans and bodes well for our future gel-based products.”
Dr. Dario Carrara, Managing Director of Antares Pharma’s Pharmaceutical and Formulation Division, stated, “Our development team has done an outstanding job in completing the filing within the projected timing. I am confident that they will continue to work with the Agency toward finalizing the Phase II protocol and then completing the studies with the same diligence exhibited to date.”
AP-1034 utilizes Antares Pharma’s proprietary Advanced Transdermal Delivery (ATD™) gel technology designed to allow delivery of active substances across the skin. The Company’s AP-1034 formulation is a cosmetic quality, clear and odorless gel designed to be rapidly absorbed through the skin following a once-a-day application on the abdomen, shoulders or thighs with reduced side effects.
