Yaupon Therapeutics announced the FDA accepted its New Drug Application (NDA) for its propriety gel formulation of mechlorethamine hydrochloride for the treatment of early stage (stages I–IIA) mycosis fungoides, the most common type of cutaneous T-Cell lymphoma (CTCL). 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. The FDA has granted Orphan Drug Status to Yaupon’s mechlorethamine gel.
Mechlorethamine gel is a water-soluble, greaseless topical chemotherapeutic agent previously approved for intravenous treatment of mycosis fungoides.
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