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February 27, 2014
07:40 EDTANACAnacor completes AN2728 ointment End-of-Phase 2 meeting with FDA
Anacor Pharmaceuticals announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for the topical treatment of mild-to-moderate atopic dermatitis with AN2728 ointment. Anacor will also initiate a long-term safety trial to evaluate the safety of intermittent use of AN2728 Ointment, 2% for up to 12 months. Subjects who complete either Phase 3 trial will have the option to roll into the long-term safety trial until approximately 500 subjects are enrolled. At least 100 subjects will be enrolled for 12 months and at least 300 subjects will be enrolled for 6 months, during which time subjects will be treated as needed under the direction of the investigator. AN2728 has demonstrated safety and efficacy in 14 other Phase 1 and Phase 2 studies. In all studies, AN2728 was generally considered safe and well-tolerated. Most adverse events were mild and largely unrelated to study drug.
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