CHARLESTON, S.C.--(BUSINESS WIRE)--Oct. 25, 2005--An industry analysis of Female Sexual Dysfunction (FSD) noted Zestra(TM) as having the potential to become the option "for a large number of women with sexual problems." In the report, Ilya Kravets, Senior Research Analyst with Rodman & Renshaw, reviews the development pipeline of pharmacological treatments for major FSD related disorders that are being developed by biopharmaceutical companies from around the world. Zestra Laboratories Inc., a privately held company, developed Zestra(TM) Feminine Arousal Fluid as a single solution for women experiencing problems with arousal, orgasm, desire and satisfaction. Unlike the potential pharmacological treatments under development by others, Zestra(TM) is available to women without a prescription. Powerful clinical study results and ease of consumer access provides Zestra(TM) with the potential to become a convenient initial option for a broad spectrum of women and warranted its inclusion in this industry report.

"We are pleased to be included by Rodman & Renshaw among the 'scarce portfolio of proven options' for women suffering with sexual difficulties," said Alan Fink, President of Zestra Laboratories. "Awareness and recommendation of Zestra(TM) is growing rapidly among women's health professionals along with consumer demand due to its robust ability to increase female sexual pleasure. The expanded clinical study we are starting should solidify the already high level of scientific recognition of non-prescription Zestra(TM)".

The industry analysis discussed Zestra Laboratories' large-scale clinical trial of Zestra(TM), which is planned to start later this year. With no current prescription drug therapies available, the report noted that a successful outcome of this trial will make Zestra the only over-the-counter product, "to have supporting evidence of efficacy from a clinical study of such magnitude."

This Phase 3 type study, which has been accepted by the National Institutes of Health (NIH), will evaluate the efficacy and safety of Zestra(TM) compared to placebo oil in 200 women diagnosed with acquired mixed interest/desire/arousal/orgasm disorders in conditions of home use in conjunction with sexual activities. The Zestra(TM) study is the only NIH-registered study to directly address women's sexual problems.

The upcoming study of Zestra(TM) will be its second randomized, placebo-controlled, double-blind trial. Primary efficacy assessment will be the subjects' assessments of "successful and satisfactory" sexual encounters as recorded in a diary (FSEP(C)). Secondary evaluations of efficacy will include the other diary questions, a subject self assessment questionnaire (Female Sexual Function Index (FSFI)(C)), two global assessment questions, a treatment satisfaction questionnaire (WITS(C)), the Beck Depression Inventory, the Dyadic Adjustment Scale (DAS), a consumer testing survey (QualiLife Consumer Testing Survey (QCTS(C)), a distress scale (Female Sexual Distress Scale (FSDS)(C)), sexual encounter frequency and drop-out rates.

The Zestra(TM) study description can be viewed at www.ClinicalTrials.gov by entering any of the following search terms: female sexual dysfunction, hypoactive sexual desire disorder, sexual arousal disorder, orgasmic disorder or Zestra. The International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication. Zestra Laboratories intends to update the trial data as the study progresses and to publish the results in a prominent peer-reviewed journal.

Zestra(TM) feminine arousal fluid is topically applied, hormone-free and is not a drug. Zestra(TM) is a patented formulation (U.S Patent 6,737,084) of two botanical oils and two extracts - specifically designed to increase sexual sensation, arousal, pleasure and satisfaction for women. Its well-studied natural ingredients are FDA recognized as dietary supplements and natural cosmetic ingredients. Non-prescription Zestra(TM) is marketed under the FDA Cosmetics Act to improve sexual experiences for women. A previous phase 2 type randomized, placebo controlled, double blind, cross-over design trial demonstrated Zestra(TM) produced these desired effects in women with and without FSD regardless of menopausal status, antidepressant usage, or oral contraceptive usage (Journal of Sex and Marital Therapy 2003;29 Supplement 1:33-44). This expanded study will increase the number and diversity of women tested with Zestra(TM). See article abstract on PubMed. The full-text article is available at: http://www.zestraforwomen.com/articles/JSMT2003.

About Zestra(TM) Feminine Arousal Fluid (U.S. Patent 6,737,084)

Zestra(TM) is designed to increase female sexual sensation, arousal and pleasure when topically applied. The ingredients in Zestra(TM) are not found in any other women's sexual product. No other product is proven to be more effective for increasing female sexual pleasure, satisfaction or libido. Ingredients: PA-Free Borage Seed Oil, Evening Primrose Oil, Angelica Extract, Coleus Extract, Vitamin C, Vitamin E and natural fragrances. More information is available at www.zestraforwomen.com

In the United States, Zestra(TM) is available nationwide in Walgreen's, CVS, Rite Aid, and Duane Reade drugstores in NYC. Zestra(TM) is also available in Asia/Pacific Rim, United Kingdom, Ireland and South Africa. To learn more visit www.zestra-asia.com, www.zestraforwomen.co.uk and www.zestra.co.za.

About Zestra Laboratories

Zestra Laboratories is a science-driven company focused on developing clinically proven consumer products for Women's Health. Since 1996, the Company has leveraged its expertise in pharmaceutical technologies and women's sexual health to "design and develop" patented consumer products for large unsatisfied markets.

CORPORATE CONTACT:
Martin G. Crosby
Chairman & Chief Science Officer
Zestra Laboratories, Inc.
4055 Faber Place Drive, Suite 300
Charleston, SC 29405
843.402.0901 (phone)
843.402.0919 (fax)
www.zestraforwomen.com

Source: Zestra Laboratories, Inc.

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