NexMed Announces Clinical Safety Data for Femprox

Apr 30, 2001, 01:00 ET from NexMed, Inc.

    ROBBINSVILLE, N.J., April 30 /PRNewswire/ -- NexMed, Inc. (Nasdaq:   NEXM),
 a developer of innovative treatments for sexual dysfunction, today announced
 the clinical results of its two safety studies on the Femprox(TM) cream
 treatment for female sexual arousal disorder ("FSAD").  Femprox(TM)
 incorporates the NexACT transdermal penetration enhancing technology with
 alprostadil, a drug well-recognized for treating male erectile dysfunction
 ("ED").  The Company is also developing Alprox-TD(R), a topically applied
 alprostadil treatment for ED, which was recently approved for sale and
 distribution in China.
     Sixty-four healthy women between the ages of 21 to 60 participated in two
 single-blind, placebo-controlled, dose escalating studies conducted at a
 medical research clinic in Miami.  In these two single dose studies, the
 subjects were divided into eight groups of eight women each.  Every subject
 received a single dose of placebo or one of six different doses of
 Femprox(TM).  The clinical results indicated that Femprox(TM) was safe and
 well tolerated at all dosages.  No serious adverse events were noted in the
 subjects tested and no abnormality in blood pressure or heart rate was
 observed.  No clinically important changes in vital signs, physical
 examinations, ECG or other safety parameters were reported.  The clinical
 results from the two single dose studies provide support for the safety of
 Femprox(TM) in healthy women.
     The results of these two studies support the findings of the presentation
 made by Dr. Edgardo F. Becher, President of the Latin American Society for
 Impotence Research, at the 2000 Annual Meeting of the American Urological
 Association (AUA) in Atlanta.  Using color duplex ultrasonography, Dr. Becher
 measured blood flow through the major arterial blood vessels in the clitoris
 before and after application of the Femprox(TM) cream on 18 female subjects
 between the ages 18 to 61.  Vital signs were obtained every 15 minutes.  In
 addition to the labial and clitoral engorgement observed, 13 subjects also
 reported a "pleasant" warm sensation.  No systemic side effects were evidenced
 and local side effects were minimal and transient.
     Approximately 47 million American women are estimated to suffer from FSAD
 with symptoms that include the inability to experience sexual arousal or
 orgasm.  The causes of FSAD are complicated and may include in some cases,
 psychological problems such as depression, stress and fatigue.  Many patients
 experience physical discomfort that may be a result of circulatory problems,
 which are often associated with menopause, diabetes and hysterectomies.
     Dr. James Yeager, the Company's Vice-President of R&D commented, "The
 clinical data from these two single dose studies are very encouraging.  Our
 Femprox(TM) product is intended to improve vaginal secretions and thereby
 increase sexual arousal and pleasure during intercourse." Dr. Yeager further
 added, "We are moving into the next phase of our Femprox(TM) program by
 conducting a "proof-of-concept" Phase II study which will enroll over 100 FSAD
 patients at 11 sites in the U.S., with the objective of determining efficacy
 and safety of Femprox(TM)."
 
     About NexMed, Inc.
     NexMed, Inc., is a pharmaceutical company with a product development
 pipeline of innovative topical treatments based on the NexACT(R) acute
 transdermal delivery technology which includes the Alprox-TD(R) and
 Femprox(TM) cream for treating ED and FSAD, respectively. NexMed is also
 developing Viratrol(R), a hand-held treatment device for herpes simplex.
 
     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 product development and acceptance,
 manufacturing, competition, regulatory and/or other factors, which are outside
 the control of the Company.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X45563541
 
 

SOURCE NexMed, Inc.
    ROBBINSVILLE, N.J., April 30 /PRNewswire/ -- NexMed, Inc. (Nasdaq:   NEXM),
 a developer of innovative treatments for sexual dysfunction, today announced
 the clinical results of its two safety studies on the Femprox(TM) cream
 treatment for female sexual arousal disorder ("FSAD").  Femprox(TM)
 incorporates the NexACT transdermal penetration enhancing technology with
 alprostadil, a drug well-recognized for treating male erectile dysfunction
 ("ED").  The Company is also developing Alprox-TD(R), a topically applied
 alprostadil treatment for ED, which was recently approved for sale and
 distribution in China.
     Sixty-four healthy women between the ages of 21 to 60 participated in two
 single-blind, placebo-controlled, dose escalating studies conducted at a
 medical research clinic in Miami.  In these two single dose studies, the
 subjects were divided into eight groups of eight women each.  Every subject
 received a single dose of placebo or one of six different doses of
 Femprox(TM).  The clinical results indicated that Femprox(TM) was safe and
 well tolerated at all dosages.  No serious adverse events were noted in the
 subjects tested and no abnormality in blood pressure or heart rate was
 observed.  No clinically important changes in vital signs, physical
 examinations, ECG or other safety parameters were reported.  The clinical
 results from the two single dose studies provide support for the safety of
 Femprox(TM) in healthy women.
     The results of these two studies support the findings of the presentation
 made by Dr. Edgardo F. Becher, President of the Latin American Society for
 Impotence Research, at the 2000 Annual Meeting of the American Urological
 Association (AUA) in Atlanta.  Using color duplex ultrasonography, Dr. Becher
 measured blood flow through the major arterial blood vessels in the clitoris
 before and after application of the Femprox(TM) cream on 18 female subjects
 between the ages 18 to 61.  Vital signs were obtained every 15 minutes.  In
 addition to the labial and clitoral engorgement observed, 13 subjects also
 reported a "pleasant" warm sensation.  No systemic side effects were evidenced
 and local side effects were minimal and transient.
     Approximately 47 million American women are estimated to suffer from FSAD
 with symptoms that include the inability to experience sexual arousal or
 orgasm.  The causes of FSAD are complicated and may include in some cases,
 psychological problems such as depression, stress and fatigue.  Many patients
 experience physical discomfort that may be a result of circulatory problems,
 which are often associated with menopause, diabetes and hysterectomies.
     Dr. James Yeager, the Company's Vice-President of R&D commented, "The
 clinical data from these two single dose studies are very encouraging.  Our
 Femprox(TM) product is intended to improve vaginal secretions and thereby
 increase sexual arousal and pleasure during intercourse." Dr. Yeager further
 added, "We are moving into the next phase of our Femprox(TM) program by
 conducting a "proof-of-concept" Phase II study which will enroll over 100 FSAD
 patients at 11 sites in the U.S., with the objective of determining efficacy
 and safety of Femprox(TM)."
 
     About NexMed, Inc.
     NexMed, Inc., is a pharmaceutical company with a product development
 pipeline of innovative topical treatments based on the NexACT(R) acute
 transdermal delivery technology which includes the Alprox-TD(R) and
 Femprox(TM) cream for treating ED and FSAD, respectively. NexMed is also
 developing Viratrol(R), a hand-held treatment device for herpes simplex.
 
     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 product development and acceptance,
 manufacturing, competition, regulatory and/or other factors, which are outside
 the control of the Company.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X45563541
 
 SOURCE  NexMed, Inc.