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| |  New Erectile Dysfunction Therapy Now Available MEQUON, WI. -- October 7, 1997 -- Schwarz Pharma, Inc. has made available their Edex(TM) (alprostadil for injection) formulation for the treatment of erectile dysfunction. Edex provides a smaller needle and is less expensive than other available alprostadil injection therapies. Schwarz Pharma received approval to market Edex from the U.S. Food and Drug Administration on June 12, 1997. In clinical trials, patients who self-injected Edex at home had a mean rate of response, with an erection sufficient for sexual intercourse, of 85 to 89 percent. Patients performed more than 15,400 self-injections over a 12-month period. Until recently experts believed impotence was primarily a psychological problem. However, new findings confirm the majority of cases are associated with other medical conditions including cardiovascular disease, diabetes and prostate or urinary bladder surgery. Some commonly used prescription medications can also cause erectile dysfunction. Edex has an excellent safety profile, determined through clinical trials involving 1,065 patients. The most frequent side effect reported in Edex clinical studies was penile pain, occurring in 15 percent of injections. Priapism, an erection lasting more than six hours, occurred in 0.6 percent of patients. The product will be marketed in convenient patient kits for at-home use in four dosage strengths -- five, 10, 20 and 40 mcg. It does not require refrigeration. Each Edex kit includes two sterile needles, one needle for preparing the Edex solution and an optional, smaller needle for injection. The product should not be used by men with known hypersensitivity to alprostadil or other prostaglandins, men with conditions might predispose them to priapism or men with penile implants or anatomical deformities of the penis.
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