Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases | Nephrology/Urology
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Drug Information
The following 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
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.
