VIVUS Announces FDA Permits Conduct of Clinical Trial With TA-1790 for the Oral Treatment of Erectile Dysfunction
BUSINESS WIRE - January 17, 2002 13:33
MOUNTAIN VIEW, Calif., Jan 17, 2002 (BW HealthWire) -- VIVUS, Inc. (Nasdaq:VVUS) today announced that as a result of filing a successful Investigational New Drug Application (IND) in December of 2001 the U.S. Food and Drug Administration will permit the Company to initiate a clinical study designed to evaluate the safety and efficacy of TA-1790 for the treatment of erectile dysfunction (ED). TA-1790, licensed from Tanabe Seiyaku in 2001, is a fast acting, highly selective, potent, oral phosphodiesterase type 5 (PDE5) inhibitor. The study will be a multi-center, double-blind, placebo-controlled evaluation of TA-1790 using RigiScan(TM) assessments of erectile response.
"This is a significant first step in the clinical development of TA-1790," stated Dr. John Dietrich, Vice President of Research and Development at VIVUS. "The trial that we will conduct is designed to assess the acute safety and efficacy of orally administered TA-1790 in subjects with erectile dysfunction."
PDE5 inhibitors, such as Pfizer Inc.'s (NYSE:PFE) Viagra(R), have been shown to be effective oral treatments for ED. Preclinical studies suggest that TA-1790 has unique characteristics that could allow it to compete in the ED marketplace.
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 international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs (TSE:PLB) to market and distribute MUSE