Friday, May 29, 2009

Vivus drug ineffective in premature ejaculation

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.

No comments: