Extensive Clinical and Pre-Clinical Data Provide New Insights Into Avanafil and Support the Compound's Potential as an Important New Treatment Option for
Erectile Dysfunction
NEW YORK and MOUNTAIN VIEW, Calif., Nov. 17 /PRNewswire-FirstCall/ VIVUS, Inc. today announced five abstracts featuring positive results from five key studies of avanafil, the company's Phase II treatment for erectile dysfunction (ED). The abstracts will be presented at the annual meeting of the Sexual Medicine Society of North America (SMSNA), November 17-20, in New York City.
The studies examined the following aspects of avanafil: enzyme selectivity; pharmacokinetics and pharmacology; the hemodynamic effects of co-administration of avanafil with nitrates in men; and Phase 2 human safety and efficacy. Detailed results will be provided at the meeting by the investigators involved with the studies. Key results include the following:
-- Avanafil demonstrated the greatest selectivity for the enzyme PDE5, which is the enzyme involved with facilitation of erections, when compared to sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis), the currently approved oral treatments for ED. This improved selectivity suggests avanafil may have fewer and/or weaker adverse events that are related to the inhibition of the other PDE isozymes compared to currently available drugs. -- Avanafil is rapidly absorbed after oral administration, with maximum concentrations in the blood stream occurring approximately 35 minutes after dosing. The compound also demonstrated a fast disappearance from blood, having a short plasma half-life of less than 1.5 hours. These pharmacokinetic properties may make avanafil well-suited as a treatment for ED, as the rapid absorption and quick disappearance are ideal for an on-demand drug for this condition. -- In an animal model, avanafil had no impact on various tests involving vision. Certain adverse ocular effects have been seen in patients taking the approved ED medications. -- In a clinical study, combined treatment with avanafil plus nitroglycerin resulted in smaller changes in blood pressure and heart rate, a shorter duration of interaction with nitroglycerin, and fewer subjects with clinically significant hypotension than did combined treatment with sildenafil and nitroglycerin. This finding suggests avanafil may be a safer PDE5 inhibitor for patients who are at risk for using nitroglycerin, although results will have to be confirmed in future trials. -- In a Phase 2 study that involved more than 280 men with mild-to- moderate ED, avanafil produced dose-related, highly significant increases in various aspects of penile function, including the ability to successfully complete intercourse. Patients were instructed to only wait 30 minutes to initiate sexual activity. In this study the drug was safe and well-tolerated by the participants.
"Taken together, these studies demonstrate the specificity, rapid onset of action, efficacy and safety of avanafil and indicate the potential of the drug to become an exciting new treatment for ED, well-matched to the needs of patients and a market that is currently seeking new options and approaches," said John Dietrich, Vice President Research and Development of VIVUS. "We look forward to continuing the development of avanafil and will be working closely with the FDA in the coming months to formulate our Phase III clinical program."
The complete list of abstract titles, numbers and presentation dates/times is as follows:
-Abstract #74 - Avanafil is a highly selective phosphodiesterase-5 inhibitor and has the potential for the treatment of erectile dysfunction, by Kotera et. al. (Tanabe); Thursday, Nov 17, 1:45-3:15 pm
-Abstract #100 - Avanafil, a highly selective phosphodieaterase-5 inhibtor for erectile dysfunction, has pharmacological properties different from sildenafil on hemodynamics and electroretinogram in anesthetized dogs, by Mochida et. al. (Tanabe), Thursday, Nov 17, 8:00-11:30 am
-Abstract #68 - Safety and efficacy of avanafil, a new PDE5 inhibitor for treating erectile dysfunction, by Kaufman et. al. (VIVUS), Friday, Nov 18, 8:30-11:50 am
-Abstract #122 - Pharmacokinetics of avanafil, a new PDE5 inhibitor being developed for treating erectile dysfunction, by Peterson et. al. (VIVUS), Friday, Nov 18, 8:30-11:50 am
-Abstract #112 - Hemodynamic effects of co-administration of avanafil and glyceryl trinitrate, by Nehra et. al. (VIVUS), Friday, Nov 18, 8:30-11:50 am
About VIVUS
VIVUS, Inc. is a pioneer in the research and development of proprietary products to restore sexual function for women and men. VIVUS' current product pipeline includes four investigational products in late stage clinical development. For women, VIVUS has initiated a Phase 2B program with ALISTA(TM) for female sexual arousal disorder and a Phase 3 program for Evamist(TM) for the alleviation of menopausal symptoms. Testosterone MDTS(R) for the treatment of hypoactive sexual desire disorder has completed Phase 2 development. 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 has completed Phase 2 development. 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 .
Avanafil is an investigational drug and has not been approved for use by the Food and Drug Administration ("FDA"). Additional studies and clinical trials will be necessary prior to the company submitting avanafil for approval to the FDA. There can be no assurance that avanafil will be approved for sale or that if approved, which claims will be allowed. 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 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.
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Leland F. Wilson http://profnet.prnewswire.com/ud_public.jsp?userid=516315 Timothy E. Morris http://profnet.prnewswire.com/ud_public.jsp?userid=516316
VIVUS, Inc.CONTACT: Timothy Morris of VIVUS Inc., +1-650-934-5200, or Maria DeFreitas of Integrated Marketing Solutions, +1-312-242-4704,maria@ims-chi.com
Web site: http://www.vivus.com/
