Pharmaceutical company VIVUS announced its official approval from FDA for its erectile dysfunction treatment drug.
A statement from Adrian Adams, CEO and President of Auxilium Pharmaceuticals (AUXL) reads, STENDRA drug, is now, “only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.”
Previously approved label on the drug recommended patients to take the drug about 30 minutes before, and is now available in multiple dosages (50 mg, 100 mg and 200 mg tablets) which can be consumed with or without food and moderate alcohol consumption (up to three drinks).
Opponent drug Pfizer Inc.’s Viagra(PFE), can be taken preferably an hour prior to sex or at least 30 minutes before.
“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.”
STENDRA was previously approved by the Food and Drug Administration in April 2012 with that 30-minute label.
Shares of Vivus Inc.,Mountain View, California, raised 37 cents to $4.25 in premarket trading.
Auxilium Pharmaceuticals has marketing rights to STENDRA in the US and Canada, which is currently musing on a takeover deal from Endo International. Sanofi SA is licensed to commercialize it in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.
Erectile dysfunction is the case when a man can no longer get or keep an erection firm enough for sexual intercourse. Based on data from the Massachusetts Male Aging Study, it is estimated that 52% of men over 40 years of age experience some degree of ED.
Stendra (avanafil), a phosphodiesterase type 5 (PDE5) inhibitor is approved for the treatment of ED in men 18 years or older.
“ED patients in my practice are looking for a safe and effective treatment option that also works fast,” commented 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.
“We are pleased with the approval of the sNDA for STENDRA,” said Seth H. Z. Fischer, Chief Executive Officer of VIVUS.
He added,”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.”
The news release states approval was based on results from Study TA-501 on 440-patient conducted at 30 sites in the US, “A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction.”