Published in Medical Devices and Surgical Technology Week, September 28th, 2003
In July, the company submitted a comprehensive data package to the U.S. Food and Drug Administration (FDA) that included a proposed phase II protocol. Following a review with FDA officials, the company was given clearance to initiate the proposed clinical study. The company intends to initiate phase II trials with APF112 in September 2003 for the treatment of pain in patients following repair of inguinal hernia.
APF112 incorporates mepivacaine, a local anesthetic with analgesic properties, which has been used extensively in...
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