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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases | Nephrology | Family Medicine | Urology

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The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Schwarz Pharma
Approval Status: Approved June 1997
Treatment Area: erectile dysfunction

General Information

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.

Clinical Results

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.

Side Effects

The most common side effect reported by 31% of patients was penile pain compared to 9% of placebo patients.