New kid on the block? Looks like MCHM (the ED gel) has some competition.
Monday February 2, 8:47 am Eastern Time
Company Press Release
NexMed Completes Phase I U.S. Clinical Study of Alprox-TD, Its Topical Alprostadil Cream to Treat Erectile Dysfunction
COMMERCE, Calif.--(BW HealthWire)--Feb. 2, 1998--NexMed Inc. (OTC BB:NEXM - news), an emerging international pharmaceutical and medical device company, announced today that it has completed a Phase I open-label study of Alprox-TD(TM), a topically applied alprostadil treatment for Erectile Dysfunction(ED).
Under the supervision of Innapharma Inc., a US-based clinical research organization (CRO), a single dose of alprostadil 0.4 percent topical cream at doses of 100 mg, 200 mg or 400 mg (corresponding to 0.4 mg, 0.8 mg or 1.6 mg of PGE1), applied to the penis in 30 males and the labi minora and majora of 30 females, resulted in no changes in vital-sign measurements or clinically significant laboratory abnormalities.
''We believe Alprox-TD is safe, effective, patient friendly and appealing,'' said Dr. Joseph Mo, NexMed's chief executive officer. ''We look forward to initiating our Phase II clinical study in the U.S. in 1998.''
Alprostadil USP (prostaglandin E1) is an off-patent drug that is recognized for treating Erectile Dysfunction (ED). The active drug is readily available for the development of NexMed's Alprox-TD, a unique topical formulation incorporating NexMed's NexACT(TM) acute transdermal drug delivery technology. The NexACT technology is based on new, specially designed ingredients that promote the rapid penetration of the active ingredient through the skin and to the site of action, and is the key to a rapid onset of action desired for a topical impotence product. The proprietary NexACT topical excipients are esters of fatty alcohols and amino acids or esters of fatty acids and amino alcohols, and chemically designed to be non-toxic and readily metabolized.
Numerous in vitro and in vivo penetration studies have shown that the NexACT enhancers are essential in the rapid delivery of alprostadil through the stratum corneum (the outer barrier layer of the skin) as well as the tissue below the skin. Comparisons of Alprox-TD with a formulation of alprostadil without enhancers indicated that the control group had no effective cumulative penetration, while Alprox-TD had a significantly high penetration profile.
It is expected that Alprox-TD will be offered in a single-dose package, which is believed to be more user friendly in use upon regulatory approval compared to the currently used injection or intraurethral alprostadil products. The product has a shelf life of two years when refrigerated or one month at room temperature.
Statement 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 acceptance, economic, competitive, governmental, results of litigation, technological and/or other factors, which are outside the control of the company.
Contact:
NexMed Inc.
Vivian Liu, 213/890-2951
or
Ronald Trahan Associates Inc.
Jeff Goodman/Constance Adolph, 617/332-0101 |
