All was not well for Vivus however, as the company released data from a trial showing that its experimental PDE5 inhibitor failed to show an effect in treating premature ejaculation. Previous studies had suggested that the drug class, which includes Pfizer's Viagra, were associated with an increased time to ejaculation in men suffering from premature ejaculation.
However, Vivus' proof-of-concept trial, investigating Viagra alongside the company's investigational compound VI-0162 and placebo, did not demonstrate an increase in the time to ejaculation.
Vivus intends to continue developing its drug for the treatment of erectile dysfunction.
GSK and Bayer achieve impressive results in long-term trials of Levitra New clinical findings on the long-term efficacy, safety and tolerability of Levitra show that men with erectile dysfunction reported clinically significant, sustained improvement in erectile function over a two-year period.
"It was impressive that 90% of men reported improvement in erectile function after taking Levitra (vardenafil HCl) over a two-year period," said Dr Wayne Hellstrom, professor of urology and chief of infertility and sexual dysfunction at Tulane University School of Medicine in New Orleans.
"These findings showed sustained efficacy with Levitra, which is an important consideration when evaluating erectile dysfunction (ED) treatment options."
In the first year of the clinical program, a total of 755 men completed a one-year treatment period with Levitra. Of those, 566 men continued to receive the drug in 10 or 20mg doses in a doubleblind study for an additional year. Of the 479 men who completed the study, two-year results showed that 92% taking Levitra 20mg and 90% taking Levitra 10mg reported improved erections at two years.
Furthermore, men were five times more likely, on average, to report success in maintaining erections sufficient for successful intercourse after taking Levitra 20mg than before they took the drug. Similar findings were seen in men taking the 10mg dose.
Levitra was well tolerated in the trial. The most commonly reported adverse events were generally mild to moderate, including headache, flushing, rhinitis (nasal congestion) and dyspepsia.
Bayer Pharmaceuticals (a subunit of Bayer AG) and GlaxoSmithKline signed a worldwide copromotion and co-development agreement for Levitra in November 2001. The FDA issued an approvable letter for the drug in July 2002, and Levitra was approved on March 6, 2003, by the European Commission based on the quality, safety and efficacy data submitted.
Friday, May 29, 2009
Saturday, April 18, 2009
Lilly Icos completes US regulatory submission for Cialis
Lilly Icos LLC, a joint venture between Eli Lilly [LLY] and the Icos Corporation [ICOS], have submitted the additional data requested by the FDA on their Cialis anti-impotence drug.
In a media release Lilly Icos said the FDA had now accepted its submission as complete, after the regulator had earlier this year requested extra clinical pharmacology and other data.
Lilly Icos expects a final regulatory decision on Cialis late in the second half of 2003, following the FDA's review of the complete response, approval of Lilly's manufacturing facilities and completion of labeling discussions.
In a media release Lilly Icos said the FDA had now accepted its submission as complete, after the regulator had earlier this year requested extra clinical pharmacology and other data.
Lilly Icos expects a final regulatory decision on Cialis late in the second half of 2003, following the FDA's review of the complete response, approval of Lilly's manufacturing facilities and completion of labeling discussions.
Thursday, October 30, 2008
Rugby world cup joke grrrrrr!!
Ritchie McCaw was walking dejectedly past the changing room doors after the game when he came accross a cellphone.
After picking it up and taking a brief look at it he knocked on the referee's door.
"here you go mate I found your cellphone"
"cheers" says the ref. "But how did you know it was mine?"
"look for yourself - 15 missed calls"
After picking it up and taking a brief look at it he knocked on the referee's door.
"here you go mate I found your cellphone"
"cheers" says the ref. "But how did you know it was mine?"
"look for yourself - 15 missed calls"
Monday, October 20, 2008
Recent Cuts
Due to recent budget cuts and the rising cost of electricity, gas, oil, and petrol ........the light at the end of the tunnel has been turned off.
We apologise for any inconvenience.
We apologise for any inconvenience.
Friday, October 17, 2008
yay clear shit!!! : D
a little while ago the only thing i ate was...well...nothing. and all i drank was water... FOR A WEEK!!!! anywho my shit was bubbling,gross,clear,very close to solid,see-thru-turd. it was awful.it felt like i was shitting jello but anyway i was on my daily route to walk to the shops and buy coke one week after my shit became solid and i 'clearly'(pardon the pun) crapped myself but this time it was pure liquid. so anyway picture this...about 300 people around me in the shop i let out this god-forsaken fart...everyone turns their heads to look at me and then i create 'the puddle'. ok so the moral of this story is look down if this happens to you. cause then you won't see the gay guy to your right in zebra skin pants and platforms smile scarily and wave.
Thursday, September 18, 2008
Cialis Postponed Until 2003
Although Eli Lilly received an approvable letter from the Food and Drug Administration for impotence drug Cialis (tadalafil), it will still be talking with the agency about additional clinical data.
The drug's new potential launch date is now 2003 or later.
Viagra, a Pfizer drug, is the best-selling medication in this category with U.S. sales of $1.5 billion in 2001, according to Pfizer.
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Viagra, a Pfizer drug, is the best-selling medication in this category with U.S. sales of $1.5 billion in 2001, according to Pfizer.
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