EDEX (alprostadil for injection) has been approved for the treatment of male erectile dysfunction, which affects more than 10 million American men. EDEX is administered by intracavernous injection and was found to be a safe and effective treatment for impotence. EDEX will be sold in four dosage strengths of 5, 10, 20, 40 mcg.
After self-injection of EDEX, 97% to 99% of patients with erectile dysfunction achieved erections sufficient for intercourse. In the studies of 1,065 people, patients performed more than 15,400 self-injections. More than 90% of patients reported satisfactory responses in both patient and partner satisfaction.
The most common side effect reported by 31% of patients was penile pain compared to 9% of placebo patients.