Merck Files NDA For Oral Impotence Drug

9 September 1997

Merck & Co has filed a New Drug Application in the USA for Viagra(sildenafil), its orally active drug for the treatment of male erectile dysfunction or impotence, according to the Marketletter's US correspondent. A phosphodiesterase type V inhibitor, sildenafil has been shown to be effective in patients suffering from impotence with a broad range of etiologies, including organic, inorganic and mixed-source dysfunction. If approved, it could offer the first pharmacological alternative to intrapenile injections in the treatment of impotence.

A near-term competitor is Zonagen's new oral formulation of phentolamine, Vasomax, but Phase III data on this product received a lukewarm reception when it was announced recently (Marketletters June 2 and 9).

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