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Connetics Extina development to resume in Q3

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Connetics plans to initiate a Phase III trial of Extina (ketoconazole 2% foam) in seborrheic dermatitis in the third quarter following discussions with FDA regarding a November 2004 "not approvable" letter, the firm says June 8. That timeline "should position Connetics to resubmit the NDA for Extina…by the end of 2006 with an anticipated review time of up to six months." The new trial is designed to demonstrate superiority to placebo foam. Extina was deemed not approvable Nov. 23, 2004 due to a lack of superiority to placebo foam in a previous Phase III trial; Connetics noted that non-inferiority to J&J's Nizoral (ketoconazole 2% cream) was demonstrated in that trial (1Pharmaceutical Approvals Monthly December 2004, p. 13)...
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