Shares of pharmaceutical company VIVUS were up as much as 12% on Thursday after the company announced FDA approval for its erectile dysfunction treatment.
The company’s drug, STENDRA, is now, “only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity,” according to a statement from the company.
VIVUS has a market cap of around $US450 million.
Auxilium Pharmaceuticals has marketing rights to STENDRA in the US and Canada. Auxilium shares, which earlier this week gained 42% after the company received a takeover offer from Irish drug company Endo Pharmaceuticals, were down about 1.5% on Thursday.
Here’s the full release from VIVUS:
VIVUS, Inc.(NASDAQ: VVUS) and Auxilium Pharmaceuticals, Inc.(NASDAQ: AUXL) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for STENDRA® (avanafil). STENDRA is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.
STENDRA is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. STENDRA is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, STENDRA helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.
“ED patients in my practice are looking for a safe and effective treatment option that also works fast,” said Wayne JG Hellstrom, M.D., FACS, Professor of Urology at Tulane University School of Medicine in New Orleans and primary investigator for the clinical trial. “In my opinion, STENDRA can be an appropriate and important treatment option because the clinical trial demonstrated that it provides a rapid onset of action in many men in as early as approximately 15 minutes.”
“STENDRA is the first FDA-approved ED drug in nearly a decade and offers men and their partners an exciting new option,” said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals. “We believe this label expansion helps position STENDRA as an exciting ‘on demand’ ED treatment and assists with the very important aspect of spontaneity for men and their partners in real world use. We believe this provides a meaningful benefit for men with ED and further underscores Auxilium’s commitment to being an innovative leader in men’s healthcare.”
“We are pleased with the approval of the sNDA for STENDRA,” said Seth H. Z. Fischer, Chief Executive Officer of VIVUS. “The positive clinical study results, now part of the label, demonstrate STENDRA’s rapid onset of action. We believe this is good news for men suffering from ED and for the healthcare providers who treat them.”
ED is the inability to attain or maintain a penile erection for sufficient sexual performance. Men may experience ED differently. Many men with ED experience one or more of the following: trouble achieving an erection; difficulty achieving an erection firm enough for penetration; or erections not lasting long enough to have successful intercourse. In the Massachusetts Male Ageing Study, it is estimated that 52% of men over 40 years of age experience some degree of ED. In addition to advanced age, recognised risk factors for erectile dysfunction include cardiovascular disease (hypertension, atherosclerosis, and hyperlipidemia), diabetes, depression, alcohol use, smoking, pelvic/perineal surgery or trauma, neurologic disease, obesity, pelvic radiation, and Peyronie’s disease.
The sNDA filed by VIVUS was based on results from Study TA-501 entitled, “A Randomised, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction.” The study was designed to assess the efficacy of two dosage strengths of STENDRA as early as approximately 15 minutes after dosing. In this 440-patient study conducted at 30 sites in the U.S., patients treated with STENDRA had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as approximately 15 minutes following administration compared to placebo. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity