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Exhibit 99.1
Contacts:
Stuart Fine Vivian Liu
Rubenstein Investor Relations NexMed, Inc.
212-843-8092 609-208-9688, ext: 101
[email protected] [email protected]
NEXMED ANNOUNCES U.S. PHASE II DATA
FOR ALPROX-TD TOPICAL ED TREATMENT
Robbinsville, NJ, November 2, 2000 -- NexMed, Inc. (Nasdaq: NEXM) a developer of
topical treatments for sexual dysfunction, today announced the clinical results
for a completed U.S. Phase II study for Alprox-TD, the Company's topical
treatment for male erectile dysfunction ("ED"). The multicenter study, conducted
at 12 clinical sites in the U.S., was randomized, parallel, double-blind,
placebo-controlled, and designed to investigate the dose-response relationships
of the efficacy and safety of three (3) different doses of Alprox-TD versus a
placebo in 161 men with mild to moderate ED. The patients were required to apply
up to ten (10) doses at home over a nine-week period and keep a daily diary.
The Phase II study results indicated that three different dose levels of
Alprox-TD were shown to be effective over placebo in sexual function endpoint
analyses, with the highest dose showing a highly significant (p=0.001) increase
in Erectile Function Domain scores under the International Index of Erectile
Function (IIEF), which is the primary efficacy endpoint for the assessment of
ED. The response to the Global Assessment Questionnaire, which measures
improvement in erectile function, indicated an efficacy rate of 73% in the
highest dose group compared to 23% in the placebo group. Other secondary
efficacy endpoints also showed statistically significant improvements when the
highest dose was compared with the placebo. Overall, the vast majority of the
side-effects observed in the study were mild in nature and consisted of a
transient burning sensation at the application site.
The causes of ED, commonly known as impotence, are often age-related. The
disease reportedly affects 10 to 20% of the male population worldwide. The ED
treatment market is projected to grow as the world's population ages. Alprox-TD
incorporates alprostadil, an off-patent vasodilator well recognized for treating
ED, with the NexACT transdermal penetration enhancing technology.
Dr. Y. Joseph Mo, president and chief executive officer of NexMed, commented,
"We are extremely encouraged by these U.S. Phase II results which mark an
important milestone in our Alprox-TD development program. The Company intends to
submit the data in final report form to the FDA for review and concurrence."
ABOUT NEXMED, INC.
NexMed, Inc., an emerging pharmaceutical and medical technology company, with a
product development pipeline of innovative topical drug treatments based on the
NexACT acute
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transdermal delivery technology. Its two lead NexACT products under development
are the Alprox-TD cream treatment for ED and the Femprox cream treatment for
female sexual arousal disorder.
Alprox-TD, Femprox, NexACT are trademarks of NexMed, Inc.
Statements under the Private Securities Litigation Reform Act: with the
exception of the historical information contained in this release, the matters
described herein contain forward-looking statements that involve risk and
uncertainties that may individually or mutually impact the matters herein
described, including but not limited to FDA review and approval, product
development and acceptance, manufacturing, competition, and/or other factors,
which are outside the control of the Company.
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