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Executive Summary

SYNTEX' FEMSTAT ANTIFUNGAL CREAM IS "APPROVABLE" IN SUSTAINED- RELEASE formulation. Syntex currently markets Femstat (butoconazole nitrate 2%) with an indication for use once a day over three days, extendable by an additional three days, for the treatment of vaginal yeast infections. FDA designated the new formulation "approvable" on March 31, according to the agency's compilation of NDA approvals for that month (see FDA's list of March approvals, p. 12). The new sustained-release formulation incorporates K-V Pharmaceutical's proprietary Site Release technology and will allow Syntex to make a one-time dosing claim. Bristol-Myers Squibb already markets a single-dose prescription antifungal, Vagistat-1 (tioconazole 6.5%) under a license from Fujisawa. Syntex may be looking down the line to an OTC version; currently, both antifungals approved by FDA for OTC treatment of vaginal yeast infections -- Schering-Plough's Gyne- Lotrimin (clotrimazole 1%) and Ortho's Monistat-7 (miconazole 2%) -- require multiple applications.

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