Adamis’ erectile dysfunction treatment hits regulatory snag as FDA calls marketing application incomplete

San Diego Biotechnology Network
San Diego Biotechnology Network
Adamis' erectile dysfunction treatment hits regulatory snag as FDA calls marketing application incomplete
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San Diego-based Adamis has stumbled in its attempt to get a lower-cost erectile dysfunction drug on the market.

The specialty pharmaceutical company ? which focuses on developing cheaper drugs for various disorders ? said the FDA had deemed its marketing application incomplete, indicating it did not include sufficient data to permit review. The experimental drug is a fast-disintegrating sublingual version of tadalafil.

Tadalafil is designed to treat erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia and forms part of a class of drugs called phosphodiesterase-5 (PDE5) inhibitors. Within this family of treatments, three oral ED tablets have already been approved: Tadalafil is the active ingredient in Lilly?s Cialis, sildenafil in Pfizer?s Viagra and vardenafil in GSK?s Levitra.

The agency has asked the company to provide longer real-t