Monday, July 14, 1997
Erectile dysfunction (ED) has long been a disorder without
a satisfactory treatment. The first biotech product to become available - Vivus Inc.'s MUSE alprostadil suppository - is far more appealing as a treatment than
either the older vacuum devices and implants or the newer injectable alprostadil
As a result, VVUS (Menlo Park, Calif.), which began selling
MUSE in January, posted $33.5 million in sales in the second quarter ended June
30, a 20 percent increase over the first quarter (see B16). Both quarters
beat Wall Street estimates, despite a period of manufacturing problems at the
Nevertheless, VVUS's honeymoon may be short-lived, and MUSE
may not have a clear market advantage for long. A variety of oral and topical
products are in late clinical development and interviews with physicians indicate
that these will be popular alternatives.
As a result, many clinicians expect that products such as MUSE
and injection therapies may end up being niche products. In fact, given the
variety of products likely to be on the market within the next few years, it
seems unlikely now that any will be dominant.
On the bright side, newer, less painful therapeutic alternatives
probably will increase the size of the ED market, and men may be willing to
try a product like MUSE or injections as second-line therapy if they fail more
palatable oral therapies.
About 140 million men worldwide suffer from ED of both organic
and psychological origin. But according to physicians, only about 10 percent
of them seek treatment. The problem is not that treatments don't work - clinicians
say that most of their patients produce erections in response to currently available
injectable agents. Rather, the issue appears to be related more to ignorance
that effective treatments are available, embarrassment about seeking treatment,
and the distastefulness of current therapeutic options.
Marketed injectable agents include The Upjohn Co.'s (Kalamazoo,
Mich.) Caverject alprostadil (prostaglandin E1 and prazosin), an injectible
launched in September 1995. Schwarz Pharma Inc. (Mequon, Wis.) received FDA
approval in June to market Edex, its injectable alprostadil product for ED.
While reviews of VVUS's MUSE are mixed, physicians said they
offer it to patients and expect that it will find a niche for itself even after
oral therapies become available.
As is often the case outside the controlled clinical trial
environment, MUSE's efficacy hasn't been as high in general use as it was in
trials. However, according to the company, its sales force has been working
with physicians on titrating doses and proper use of the product, and the company
said it has seen improvements in efficacy with this effort.
Consultant, Grayslake, Ill.
Ferguson is an emergency medicine and clinical pharmacology specialist, as well as a consultant to the drug industry in designing clinical trials for ED. The treatment outcome for ED, he said, is always based on multiple factors, both organic and psychogenic.