Dr.Joe's Data Base


IMPOTENCE DRUG TRIALS PUBLISHED IN NEW
ENGLAND JOURNAL (4/3)

By KRISTIN JENSEN
c.1996 Bloomberg Business News

BOSTON -- Pharmacia and Upjohn Inc. researchers say three studies, published in Thursday's
issue of the New England Journal of Medicine, show the company's drug for male impotence is
highly effective.

Researchers from Upjohn, which merged with Pharmacia in November, found that an injection of
the company's Caverject Sterile Powder allowed satisfactory sexual intercourse for 87 percent of
men affected by the disorder.

Caverject was approved for marketing by the U.S. Food and Drug Administration last July, based
on these studies and eight others. Results of the studies are being published now.

``Publication of this paper will increase physician awareness of an important therapy option for the
millions of patients suffering with this condition,'' said Otto Linet, the lead author of the study and
clinical research director for Pharmacia & Upjohn.

Currently, between 10 million and 20 million American men can't consistently attain and maintain a
penile erection for intercourse.

Caverject is injected into the base of the penis with a thin needle and produces an erection within
five to 20 minutes. It does so by relaxing the smooth muscle and dilating the major artery in the
penis.

The studies concluded that side effects were ``tolerable.'' In about half the men, mild-to-moderate
pain was reported after 11 percent of the injections, researchers said. Other side effects include
abnormally prolonged erections and the formation of hardened, fibrous tissue. Erections lasting
longer than six hours occurred in 1 percent of the men tested, while hardened tissue occurred in 2
percent, researchers said.

The drug is a synthesized version of alprostadil, a naturally occurring form of the hormone
prostaglandin E-1. Prostaglandin also keeps open an artery in infants who might need heart surgery.

The FDA approved Caverject for men with dysfunction from neurologic, vascular, and
psychological causes. It shouldn't be used by men with sickle cell anemia, multiple myeloma,
leukemia, deformation of the penis or penile implants.

And in an editorial in the journal, Dr. Larry Lipshultz of Baylor College of Medicine wrote that
doctors should be careful not to overprescribe the treatment to men affected by impotence.

``It should be emphasized that the proper treatment of such men requires individualized evaluation
and depends on the cause of their erectile dysfunction,'' Lipshultz wrote.

When the drug was approved in July, analysts said Caverject could generate as much as $100
million a year in sales for the company.

It's used in more than 25 other countries, including the United Kingdom, France and Italy.