Yaupon seeks FDA marketing approval of mechlorethamine gel for mycosis fungoides

Yaupon Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its propriety gel formulation of mechlorethamine hydrochloride (mechlorethamine). Yaupon is seeking U.S. marketing approval of its mechlorethamine gel for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL). Yaupon's formulation is a water-soluble, greaseless topical gel.

“If approved, our proprietary product would be the first topical formulation of mechlorethamine to be manufactured under Good Manufacturing Practices and made broadly available to people living with this common type of CTCL”

Mechlorethamine is a chemotherapeutic agent previously approved for intravenous treatment of mycosis fungoides, the most common type of CTCL. Currently, topical mechlorethamine preparations are recommended for treatment of early stage CTCL by the National Comprehensive Cancer Network (NCCN). However, there are no FDA-approved topical mechlorethamine drugs, limiting availability to non-standardized, pharmacist-compounded preparations. These preparations are typically petroleum jelly based formulations.

"If approved, our proprietary product would be the first topical formulation of mechlorethamine to be manufactured under Good Manufacturing Practices and made broadly available to people living with this common type of CTCL," said Yaupon Chairman and CEO Steve Tullman. "We look forward to collaborative discussions with the FDA during the course of the regulatory process."

The FDA has granted Fast Track Status and Orphan Drug Status to Yaupon's mechlorethamine gel. The NDA submission includes data from a pivotal, multi-center clinical study of this topical mechlorethamine gel in patients with early stage mycosis fungoides, which met its primary and secondary endpoints. The primary endpoint was an assessment of lesion severity. Adverse events potentially related to Yaupon's formulation include dermatitis (skin irritation, pruritus and erythema) and hyperpigmentation. Dermatitis ranged from mild to moderately severe.