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VVUS - Vivus Inc

post #1 of 170
Thread Starter 


VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity and sexual health. The pipeline includes: Qnexa™, which is in phase 3 for the treatment of obesity and phase 2 for the treatment of type 2 diabetes; Testosterone MDTS®, for which a phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); and avanafil, for which a phase 2 study has been completed for the treatment of erectile dysfunction (ED). For more information on clinical trials and products, please visit the company's web site at http://www.vivus.com.
post #2 of 170
Thread Starter 
Up 19% today, analyst price target of $10
post #3 of 170

phase III

VIVUS Initiates Second Pivotal Phase 3 Trial of Avanafil for Treatment of Erectile Dysfunction
REVIVE-Diabetes (TA-302) Study to Evaluate Avanafil for Treatment of Erectile Dysfunction (ED) in Men with Diabetes, One of the Most Common Causes of Erectile Dysfunction

VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a second pivotal Phase 3 study of avanafil, its investigational new drug for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor.

The study, REVIVE-Diabetes (TA-302), is a multicenter, randomized, double-blind, placebo-controlled trial and will evaluate the safety and efficacy of avanafil in the treatment of ED in men with type 1 or type 2 diabetes. Subjects who meet the inclusion criteria will undergo a four-week non-treatment run-in period followed by 12 weeks of treatment. The co-primary endpoints of the study will be improvement in erectile function as measured by changes in the sexual encounter profile (SEP) questions 2 and 3, and improvement in erectile function as measured by the erectile function domain score of the International Index of Erectile Function (IIEF). The SEP is a self-administered patient diary and the IIEF is a patient questionnaire; both are used as standard diagnostic tools to assess erectile dysfunction. REVIVE-Diabetes is the second of three planned pivotal studies in the avanafil Phase 3 development program.

“There has not been a new treatment option for men with ED in more than five years,” stated Andrew McCullough, MD, associate professor of clinical urology, NYU School of Medicine and REVIVE-Diabetes clinical investigator. Early data suggest that avanafil may provide a fast-acting therapy with a short half-life, which, if approved, may represent a noteworthy advance for the millions of men living with ED and searching for new options.”

Diabetes is one of the most common causes of ED; clinical data suggest that at least 50 percent of diabetic men will experience difficulties with erectile function. Men with diabetes are up to three times more likely to have ED than non-diabetic men and appear to experience it earlier in life. The significance of ED increases with the severity and duration of diabetes as well as with advanced age.

“Evidence suggests that there is room for significant improvement in the current treatment of ED,” Charles Bowden, MD, senior director, clinical development for VIVUS. “We’re pleased with the promising results demonstrated thus far with avanafil, and with the momentum behind our Phase 3 program. Enrollment in our first pivotal study, REVIVE, initiated in December to evaluate avanafil in ED, is ongoing. REVIVE-Diabetes will be conducted at many of the same sites as REVIVE.”

It is expected that this study will enroll approximately 375 patients at about 30 sites in the United States. Subjects are instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. REVIVE-Diabetes will study two doses of avanafil. More information about the trial can be found at http://www.clinicaltrials.gov.

As previously disclosed, VIVUS has entered into a $30 million funding collaboration with Deerfield Management to fund the Phase 3 program.
post #4 of 170

worth keeping an eye on...trials to complete soon

didnt mean to edit...
post #5 of 170
anyone watching this? seems to be forming a nice ascending triangle
post #6 of 170

looking up... good start to the week...one of my "heads up" stocks this week...
post #7 of 170
lookin good
post #8 of 170
Originally Posted by BranRx View Post
lookin good
yes,yes it does...i looked yesterday and thought about getting in at 4.50 but opted not to...of course...big volume day today too
post #9 of 170
VVUS in for atleast a good start this week.
post #10 of 170
really long upper wick last friday.
post #11 of 170
Originally Posted by Brenna34749 View Post
KATX about to explode? Lots of publicity. I think KATX could move a lot tomorrow.

Watch KATX tomorrow
post #12 of 170
still running...

post #13 of 170
This looks to be reversing. Closed above previous swing high in late June/early July. 3 up days
post #14 of 170
Up 80% today LOOK might be a good play
Drug stocks edge higher; Vivus rockets
10:18a ET September 9, 2009 (MarketWatch)
BOSTON (MarketWatch) -- Drug stocks edged higher in early action Wednesday as shares of Vivus Inc. rocketed on positive late-stage clinical data for its weight-loss drug Qnexa.

The NYSE Arca Pharmaceutical Index was up marginally at 281.30 and the NYSE Arca Biotechnology Index rose 0.4% to 928.21.

Shares of Vivus were up over 70% at $11.97.

Early Wednesday, Vivus said that two Phase III clinical trials showed Qnexa was effective in lowering weight when it was tested against a placebo. The company added patients using Qnexa also showed improvements in blood pressure, lipid levels and type 2 diabetes.

Vivus added that it plans to file for U.S. regulatory approval by the end of the year and is actively seeking a pharmaceutical marketing partner.

Mylan Inc. shares were down 3% at $14.29. The generic drugmaker said late Tuesday that its chief financial officer, Jolene Varney, has left the company and a search is underway for a successor. According to a report in the Pittsburgh Tribune-Review, Varney had only been on the job for about three months.
post #15 of 170
what the hell!
post #16 of 170
Some movement... this may make a second run after consolidation, but we'll see

post #17 of 170
Thread Starter 
+3% move today, phase 3 goals have been met for their ED drug. Two more studies in the works.
post #18 of 170
it was funny how those guys were giving ponytail a hard time about knowing so much about the ED drug
post #19 of 170
Thread Starter 
He should have rolled with it.

I mix my viagra with my cereal every morning.
post #20 of 170
Originally Posted by StockJock-e View Post
+3% move today, phase 3 goals have been met for their ED drug. Two more studies in the works.
Whoa ED drug? What can beat Cialis? It gives you the best bang for your buck of the big three.....
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