LOL here's your "dick creme"
MacroChem: Topiglan Helps Erectile Function
New York, Sep 06, 2001 (123Jump via COMTEX) -- Drug company MacroChem Corp.
(MCHM) announced that Topiglan, a topical drug used to treat Erectile
Dysfunction (ED), achieved statistically significant results in a recently
completed, pivotal Phase 3 clinical trial.
However, the drug failed to enable patients maintain erection until completion
of intercourse. This ability is a benchmark required for approval of drugs used
to treat ED.
Topiglan contains 1% alprostadil, a synthetic hormone found in the male
reproductive system, and 5% Soft Enhancer of Percutaneous Absorption (SEPA) -
the company's drug-absorption excipient.
Men apply Topiglan to the glans, or head, of the penis. According to MacroChem,
Topiglan's alprostadil is safe for men with heart problems, unlike Pfixer Inc.'s
(PFE) Viagra.
Drugs taken orally may produce side effects affecting the central nervous and
cardiovascular systems because the agent must be distributed by the circulatory
system throughout the body to reach the intended site of action.
Topligan achieved significant results on six questions related to erectile
function, including, frequency of erections, confidence in ability to get and
maintain an erection and ability to maintain an erection through ejaculation.
Typically, when a drug is released from the site, it enters the bloodstream and
passes through the lungs. With Topiglan, 90% of alprostadil is metabolized in
the lungs, which accounts for the fact that side effects at the site of
application were mild or moderate.
The Lexington, Massachusetts company said that the early results are from a
group of "protocol-conforming" patients who followed all instructions and
conditions, rather than the full population of the study. Regulatory submissions
normally include only results of the whole study.
MacroChem announced that it will use a reformulated product and new dispensers
to deliver "considerably more drug" in further studies.
ED is characterized by the inability of a man to respond to sexual stimulation
with a penile erection of sufficient firmness to penetrate his partner and to
maintain that firmness through ejaculation.
It is estimated that more than 30 million men in the United States suffer some
degree of ED - be it mild, moderate or severe. Analysts expect that, by 2004, ED
drug sales will total between $4 billion and $6 billion.
MacroChem is engaged in the development of transdermal drug-delivery systems
that allow drugs to be absorbed through the skin via creams, gels and patches.
The company attracts business partners by applying its SEPA system to
FDA-approved drugs.
MacroChem has also developed a series of MacroDerm low molecular weight polymers
for cosmetic use and the topical delivery of pharmaceuticals.
Market capitalization is $173 million. The company competes against Cygnus Inc.
(CYGN), Elan Corporation plc (ELN) and Novartis AG (NVS).
Shares in MacroChem, which lost 7 cents, or 1.13%, to 6.15, in regular trading
Wednesday, traded lower at 5.46 in the extended session after the announcement.
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