Clinical Results from Zonagen's Vasofem Study Show Promise for Treatment of Female Sexual Dysfunction.

Business Editors & Health/Medical Writers

THE WOODLANDS, Texas--(BW HealthWire)--Sept. 7, 2000

Zonagen, Inc. (Nasdaq:ZONA)(PCX:ZNG) announced that encouraging data from an in-office study of the company's Vasofem(TM) product for the treatment of Female Sexual Dysfunction (FSD) will be presented today at the FIGO World Congress of Gynecologists in Washington D.C. Dr. Eusebio Rubio of Mexico City, principal investigator in the study, will present the data.

FSD is a multicausal and multidimensional condition involving biological, psychological and interpersonal components. The condition is age-related, progressive and highly prevalent, affecting 20-50% of all women in the U.S. Lack of sexual interest, inability to experience orgasm, lubrication difficulties, and finding sex not pleasurable are some of the most common complaints in FSD.

The randomized, double-blind, placebo controlled, cross-over study enrolled 42 post-menopausal women diagnosed with Female Sexual Arousal Disorder (FSAD), a subset of FSD, of whom 18 were also using Hormone Replacement Therapy (HRT). The objective of the study was to collect both physiological and subjective information on the effects of Vasofem(TM), administered either as an oral tablet or vaginal solution, under neutral and erotic visual stimulation.

According to Dr. Rubio, "This study indicates that phentolamine, a vasoactive agent, increases genital blood flow and improves subjective feelings of arousal, warmth, tingling and lubrication, especially in women with arousal problems who are also using HRT." Compared to placebo, the 40 mg oral Vasofem(TM) results showed a 45% difference in blood flow (p less than 0.02), and also statistically significant differences (p less than 0.03) for the subjective recordings of arousal, lubrication, engorgement, tingling and warmth.

"We are encouraged with the results of this study," said Joseph Podolski, president and CEO of Zonagen. He added, "We are now conducting an 80 patient placebo-controlled study of oral Vasofem(TM) in Mexico in women with FSD in a natural, at-home use setting during regular sexual activity to further substantiate the in-office findings."

Vasofem(TM)'s Investigational New Drug application (IND) in the U.S. has recently been upgraded by the Food and Drug Administration to a partial clinical hold, allowing the company to pursue a U.S. clinical development program. A complete clinical hold was imposed last year after findings of brown fat proliferations in a two-year rodent carcinogenicity study were observed. The rodent study was part of the company's NDA program for its male erectile dysfunction product, Vasomax(R). The company has decided not to run any additional studies in the U.S. until all of the FDA preclinical issues have been satisfactorially resolved.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including but not limited to those relating to the uncertainties involving the company's early stage of development, clinical trial results and FDA approval in the U.S. and approval of regulatory authorities in other jurisdictions, substantial dependence on one product, history of operating losses, future capital needs and uncertainty of additional funding, uncertainty of protection for patents and proprietary technology, litigation, governmental regulation, limited sales and marketing experience and dependence on collaborators, manufacturing uncertainties and reliance on third parties, competition and technology change, product liability and availability of insurance, and other risks identified in the company's Annual Report on Form 10-K for the year ended Dec. 31, 1999, as filed with the Securities and Exchange Commission.