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

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