VIVUS Announces Positive Results in Phase II Trial Evaluating ALISTA For the Treatment of Female Sexual Arousal Disorder
MOUNTAIN VIEW, Calif.--Nov. 29, 2001--VIVUS Inc. (Nasdaq:VVUS)
today announced positive results from a Phase II study of ALISTA(TM),a proprietary topical formulation of alprostadil (prostaglandin E1)for the treatment of Female Sexual Dysfunction (FSD).
This study was a double-blind, placebo-controlled,
crossover-design trial that evaluated patient responses to doses of ALISTA administered in the clinic in conjunction with visual sexual stimulation. A total of 79 patients with a primary complaint of Female Sexual Arousal Disorder (FSAD) were treated at six investigational
sites.
Study endpoints were based on subjective patient ratings of their level of sexual arousal, level of satisfaction with sexual arousal, and level of sexual satisfaction. All endpoints were rated on categorical scales (none, low, moderate, high, very high). Ratings
were made at baseline (prior to dosing), and at several time points over at 2-hour period following dosing.
Significant differences between the responses to ALISTA and placebo were observed for level of sexual arousal, patient satisfaction with level of arousal, and level of sexual satisfaction.
These differences were observed as early as five minutes after dosing, and were maintained throughout the period of sexual stimulation. The doses of ALISTA evaluated in this study were well tolerated.
"This is a landmark study and believed to be the first well controlled clinical trial to demonstrate improved sexual arousal and satisfaction in women with FSAD. Importantly, prostaglandin E1 (PGE1)
is a naturally occurring compound found in the human body, and local application has the potential to limit systemic side effects,"
commented Dr. Andre T. Guay, Director of the Center for Sexual Function at the Lahey Clinic Northshore, Boston, Massachusetts.
The Journal of the American Medical Association reported that 43% of women ages 18 to 59 experience some form of sexual dysfunction.
Researchers have classified the range of symptoms seen in female sexual dysfunction into four subcategories: desire, arousal, orgasmic and sexual pain disorders.
ALISTA is believed to increase blood flow to the female genitalia,thereby promoting engorgement and other natural processes that occur during sexual stimulation. With both issued and pending patents, the Company believes it has the dominant patent position for the local delivery of prostaglandins, such as alprostadil, in the treatment of
women with FSD.
VIVUS Inc. is a pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. Current development programs target Female Sexual Dysfunction (FSD), Erectile
Dysfunction (ED) and Premature Ejaculation (PE). The Company developed and markets in the U.S. MUSE(R) (alprostadil) and ACTIS(R), two innovations in the treatment of erectile dysfunction, and has
partnered with Abbott Laboratories (NYSE:ABT) for the internationalmarketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs (TSE:PLB)
to market and distribute MUSE.
This news release contains forward-looking statements about the potential commercialization of products in treating male and female sexual dysfunction and reflects management's current beliefs. However,as with any pharmaceutical under development, there are significant
risks in development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies will confirm the preliminary results discussed in this news release or that
any product will receive regulatory approval for any indication.
Further, even if the Company were to receive regulatory approval for a product, there could be no assurance that such a product would prove to be commercially successful. Please see the Company's filings with the Securities and Exchange Commission including, without limitation,
the Company's Form 10-K and Forms 10-Q, which identify these and other risks and uncertainties that may cause actual results or events to differ materially from those described in this news release.
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CONTACT: VIVUS Inc.
Richard Walliser, 650/934-5200
ir@vivus.com
www.vivus.com
or
Lippert/Heilshorn & Associates Inc.
Bruce Voss, 310/691-7100 (Investor Contacts)
bvoss@lhai.com
Jody Cain, 310/691-7100 (Investor Contacts)
jcain@lhai.com
Elissa Grabowski, 212/838-3777 (Media Contact)
egrabowski@lhai.com
www.lhai.com |
