The benefit of Takeda’s big pharma backing will kick in if the drug hits the market. Takeda has more than 2,000 people in its sales force who can potentially market the drug on-the-ground to health care providers. That compares to the roughly 200 person team Eisai put behind Belviq’s launch.And Takeda has experience in marketing diabetes-related drugs with Actos.
If Auxillium announce that Endo is mainly interested in Stendra ....VVUS =$20
VVUS shares are near a 52 week low.
Stendra has the fastest onset of action in the PDE 5 inhibitor class.
VVUS ' partner, AUXL, just received a takeover bid.
Shenzi cannot believe that in 15minutes 11.59 inches is possible even after FDA okays. Probably he is so much involved in shorting business that he only believes Stendra heps only getting short after 15minutes.
Stendra is the only erectile dysfunction medication that can be taken as little as 15 minutes before sex.
This is such a perfect drug for the short attention span, immediate gratification society we now live in and so kudos to VIVUS
Stendra is available in multiple dosage strengths (50mg, 100mg and 200mg 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 A helped more men achieve an erection in as early as about 15 minutes that lasted long enough to successfully complete sexual intercourse.
PROVIDES A RAPID ONSET OF ACTION
"ED patients in my practice are looking for a safe and effective treatment option that also works fast," said Wayne Hellstrom, Professor of Urology at Tulane University School of Medicine in New Orleans and primary investigator for the clinical trial, adding: "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."
Adrian Adams, chief executive and president of Auxilium, said: "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."
CLINICAL BACKING FOR LATEST INDICATION
The sNDA filed by Vivus was based on results from Study TA-501 titled, "A Randomized, 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 USA, 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 prescribin
Adam Feuerstein that hit the nail on the head, calling Contrave the “Goldilocks” diet pill that has shown efficacy squarely between the efficacy of Qsymia and Belviq. He points out how the average one-year user of Orexigen’s weight-loss drug loses 5% of his/her body weight, versus 3% for Belviq and 9% for Qsymia.
Rival drugs used to treat erectile dysfunction, like Pfizer Inc.'s Viagra, are supposed to be taken at least 30 minutes before sex.
The Food and Drug Administration approved Stendra in April 2012 with that 30-minute label. But Vivus has sought a new label after finding in studies that some patients were able to have sex as little as 15 minutes.
Vivus also makes the obesity drug Qsymia. Last fall, it gave the rights to sell Stendra in the United States and Canada to Auxilium Pharmaceuticals Inc. in a deal that could be worth $300 million, depending on royalty payments.