VIVUS: FSD ALISTA beantragt! :) - 500 Beiträge pro Seite

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VIVUS Files With FDA To Start Clinical Testing
For Female Sexual Dysfunction

MOUNTAIN VIEW, Calif.--(BW HealthWire)--Sept. 21, 2000--VIVUS,
Inc. (Nasdaq:VVUS) announced today that it has filed an
Investigational New Drug application with the US Food and Drug Administration (FDA) for its female sexual dysfunction (FSD) product, ALISTA(TM). The Company plans to initiate human clinical testing soon after the FDA`s 30-day waiting period, baring agency comments.

"Female sexual dysfunction is estimated to effect more than 40 percent of women," said Leland F. Wilson, President and CEO of VIVUS, Inc. "VIVUS once again is in the forefront of a major, new medical market. We believe our strong patent portfolio and proprietary formulation bode well for ALISTA."

ALISTA is a proprietary topical formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of a naturally-occurring vasodilating agent found in the body. It is the same active ingredient found in VIVUS` product, MUSE(R), used to treat
male erectile dysfunction. ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation.

FSD is currently thought to represent a spectrum of sexual
disorders with both psychogenic and organic causes that have been classified into four major categories: desire, arousal, orgasmic and sexual pain disorders. VIVUS` clinical program is designed to evaluate ALISTA in females with a primary complaint of sexual arousal disorder,
or FSAD. The Company plans to study the safety and efficacy of ALISTA in its initial clinical studies. Clinical data from this and other studies will assist in the design of larger clinical trials required for FDA marketing approval.

VIVUS, Inc. is a leader in the development and commercialization of innovative therapies for the treatment of sexual dysfunction and urologic disorders in men and women. The Company developed and manufactures the product MUSE(R) (alprostadil) and the medical device ACTIS(R), two innovations in the treatment of male erectile dysfunction (ED). The Company has filed for regulatory approval with
the FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) for ALIBRA(R), its second-generation drug for the treatment of ED, and expects marketing clearance between late 2000 and mid 2001. Currently VIVUS markets MUSE in the United States, and has
partnered with Abbott Laboratories (NYSE: ABT) for the international marketing and distribution of its male ED products. VIVUS has additional research and development programs in premature ejaculation and ED.

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VIVUS Begins Phase II Study With ALISTA For The Treatment of Female Sexual Dysfunction

MOUNTAIN VIEW, Calif.--(BW HealthWire)--Jan. 23, 2001--VIVUS, Inc. (Nasdaq NM:VVUS - news) today announced enrollment of patients in a Phase II study to evaluate the safety and efficacy of the Company`s female sexual dysfunction (FSD) product, ALISTA(TM). This multi-center, double-blind, placebo-controlled study is intended to evaluate the sexual response with ALISTA in women with a primary diagnosis of Female Sexual Arousal Disorder (FSAD).

``This is an exciting time for VIVUS as we progress to the next phase of clinical development for our lead product intended to treat women with FSAD,`` said Leland F. Wilson, President and CEO. ``Results from this study will provide preliminary data on the efficacy of ALISTA in a population of women with FSAD, and will help us to design the larger pivotal studies that will be required for global regulatory submissions.``

Researchers have classified the range of symptoms seen in FSD into four subcategories: desire, arousal, orgasmic and sexual pain disorders. The VIVUS clinical program is designed to evaluate ALISTA in women with a primary complaint of arousal disorder.

ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of a naturally occurring vasodilating agent. It is the same active ingredient found in the VIVUS product MUSE®, which is used to treat male erectile dysfunction. 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 specialty 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. The Company developed and markets in the U.S. MUSE® (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE: ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs to market and distribute MUSE . VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA(TM), during the fourth quarter of 2000.