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VIVUS Completes Enrollment in Phase 3 Study of Evamist(TM) for Treatment of Menopausal Symptoms

Posted on: Tuesday, 11 October 2005, 09:01 CDT

MOUNTAIN VIEW, Calif., Oct. 11 /PRNewswire-FirstCall/ -- VIVUS Inc. today announced it completed enrollment in its pivotal Phase 3 clinical study of its investigational drug Evamist(TM) (Estradiol MDTS(R)), an estradiol spray for the treatment of vasomotor symptoms associated with menopause. This Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Evamist. The primary endpoint is the reduction in the frequency and severity of moderate-to-severe vasomotor symptoms associated with menopause at weeks 4 and 12 of the study. Over 400 patients were enrolled at 43 centers throughout the United States. The study was initiated in December 2004 under a Special Protocol Assessment ("SPA") with the Food and Drug Administration ("FDA").

The SPA is a formal agreement that designates the agreed upon terms and conditions under which VIVUS will conduct and analyze the data from its Phase 3 trial. The SPA provides official confirmation from the FDA that the protocol design is sufficient for a Phase 3 trial which, if completed as agreed, can form the basis of the submission of a New Drug Application ("NDA") that will include an efficacy label claim for Evamist for the relief of moderate to severe vasomotor symptoms associated with menopause.

"Completion of enrollment in the pivotal Phase 3 trial for Evamist represents yet another corporate milestone for VIVUS," said Peter Tam, Senior Vice President of Product and Corporate Development of VIVUS. "We believe Evamist has the potential to provide a practical and convenient option for the millions of women seeking a better treatment option for their menopausal symptoms."

The company expects to submit the NDA for Evamist mid year 2006. About Evamist

Evamist is an investigational drug that has not been approved by the FDA or any other regulatory authority. Evamist is a small, hand-held, easy-to-use spray that is designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin. The Evamist applicator is placed gently against the skin and an actuator button is pushed. A light spray containing a proprietary formulation of estradiol is then released, where it is absorbed into the dermal layer. This method of delivery eliminates the requirement to touch the formulation, and may decrease the transfer of the active ingredient to other areas of the body or to other persons. Estradiol is released into the blood stream on a sustained basis over 24 hours, providing a practical and convenient once-a-day dosing regimen. Evamist is believed to be the first transdermal estradiol spray delivery system under development in the United States. Evamist is fast drying, non-irritating and invisible after application. VIVUS licensed Evamist for the U.S. market from Acrux Limited in February 2004.

About Menopause

Approximately two million American women turn 50 each year. Women naturally enter into menopause usually between the ages of 45 and 55; however, surgical menopause may happen at any age. Menopausal symptoms occur when the ovaries stop producing estrogen. Symptoms include hot flashes, discomfort or pain during sexual intercourse due to vaginal atrophy (thinning of the vagina), and changes in skin and hair.

About VIVUS

VIVUS Inc. is a pioneer in the research and development of proprietary products to restore sexual function for men and women. VIVUS' current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has initiated its Phase 2B programs with ALISTA(TM) for female sexual arousal disorder, and Evamist(TM) for the alleviation of menopausal symptoms. VIVUS has completed Phase 2 development for Testosterone MDTS(R) for the treatment of hypoactive sexual desire disorder (HSDD). The MDTS system is a patented new-generation, transdermal drug delivery technology that delivers drugs through the skin. For men, VIVUS is developing avanafil for erectile dysfunction, which is currently in a Phase 2 program. VIVUS currently markets MUSE(R) (alprostadil) suppository for the treatment of erectile dysfunction in the U.S. and internationally through distributors. For more information on clinical trials and products, please visit the Company's web site at http://www.vivus.com/.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate,""believe,""forecast,""estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2004 and periodic reports filed with the Securities and Exchange Commission.

CONTACT: VIVUS Inc. Timothy E. Morris Chief Financial Officer +1-650-934-5200

VIVUS Inc.

CONTACT: Timothy E. Morris, Chief Financial Officer, of VIVUS Inc.,+1-650-934-5200

Web site: http://www.vivus.com/

Source: PRNewswire-FirstCall

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