Yaupon submits NDA for mycosis fungoides topical gel

Submitted by Ross Bonander Wed 10/05/2011

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Yaupon Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration for Yaupon's proprietary gel formulation—both greaseless and water-soluble—of mechlorethamine, and the FDA accepted the application.

Yaupon hopes to bring their gel to the US market as a treatment option against the early stages of a very common form of cutaneous T-cell non-Hodgkin's lymphoma known as mycosis fungoides.

Mechlorethamine is hardly a new drug for the treatment of mycosis fungoides (MF). It has been used as an intravenous chemotherapeutic agent against MF long enough to have become part of the standard treatment guidelines published by the National Comprehensive Cancer Network (nccn.org).

Yaupon's gel however would be the first topical formula of the drug. Previously, the FDA granted the gel orphan drug status.

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