Friday December 22
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Dec. 22, 2000--VIVUS, Inc. (Nasdaq: VVUS) today announced receipt of 510(k) approval from the Food and Drug Administration (FDA) for over-the-counter (OTC) marketing of ACTIS(R), an adjustable constriction band used to enhance the erection process in men with erectile dysfunction (ED). ACTIS received FDA marketing clearance in 1996 as a prescription device and was introduced into the marketplace in 1997.
"Our ACTIS OTC marketing efforts have already begun," commented Terry Nida, Vice President of Marketing at VIVUS. "Our plan calls for selling ACTIS through major pharmacy channels and through e-commerce efforts. Given its safety record, we expect that the product will be well received by consumers."
VIVUS has an agreement with ivpcare to handle phone (1-800-424-9002) and Internet (www.ivpcare.com) orders for ACTIS.
Internationally, ACTIS will be sold OTC by Abbott Laboratories (NYSE: ABT), which also markets VIVUS' erectile dysfunction prescription drug MUSE(R) (alprostadil).
ivpcare is a national specialty pharmacy dedicated to providing comprehensive pharmaceutical care to patients dealing with infertility, multiple sclerosis and arthritis. ivpcare works closely with clinicians and payors to provide services to meet their specific needs and address the challenges faced when caring for patients seeking treatment for these complicated disease states.
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(R) and ACTIS(R), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories for the international marketing and distribution of its male ED products. VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA(TM), during the fourth quarter of 2000.
Note to editors and investors: Additional written materials, recent releases and Company information are available through a variety of sources, including the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand Service (1-888-329-5719).
This news release contains forward-looking statements that involve risks and uncertainties regarding VIVUS Inc.'s operations and future results. Please see the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's Form 10-Ks and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Contact: VIVUS, Inc.
Dick Walliser, 650/934-5264
Lippert/Heilshorn & Associates, Inc.