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