Archive for July, 2008

Ready Drugs to Take on Viagra

Saturday, July 26th, 2008

When people think impotence, they think Viagra. Soon, that may change.

Two “sons of Viagra” are close to reaching the market, and doctors say these new drugs may have some definitive advantages. They work in a similar way, but they seem to act faster and cause fewer of the trademark Viagra side effects: headaches, nasal congestion, flushed faces and blue vision.

To tout the new drugs’ advantages, their makers can unleash some serious marketing firepower — sufficient to give Pfizer Inc., which effectively created the pharmaceutical market for alleviating erectile dysfunction when it launched Viagra a few years ago — a run for its money. A lot of money is at stake. Viagra’s sales totaled $1.3 billion last year and are projected to rise to $1.6 billion this year.

Cialis and vardenafil act in the same way as Viagra, by blocking an enzyme called phosphodiesterase-5, or PDE-5, and in the process relaxing smooth muscle cells in the penis and elsewhere. In causing these muscles to relax, the drugs effectively increase blood flow to the penis.

Though they work in similar ways, Cialis, vardenafil and Viagra are distinctly different chemical entities. Some urologists say vardenafil and Cialis are more effective at blocking the PDE-5 enzyme and hence potentially more potent than Viagra. This means they could act as well as, or better than, Viagra at smaller doses. They also interact with fewer other molecules and hence might have fewer side effects.

In the looming marketing battle, Viagra starts out with some advantages, Pfizer argues. The company has conducted more than 80 studies of Viagra, says Michael Widlitz, a vice president at Pfizer, and “no competitor can hope to ascend this mountain of efficacy and safety data.”

Drug-industry executives estimate that 30 million European men suffer from

No one can make a definitive comparison between the drugs because there have been no public head-to-head clinical trials. But the newcomers are already zeroing in on what they believe are their drugs’ advantages over Viagra. Cialis, for instance, gave men improved ability to have sex for up to 36 hours, according to results from a study presented at a medical conference recently. In contrast, Pfizer recommends that men have sex within four hours of taking Viagra.

“Patients should not have to worry about watching the clock and planning their sex life around the time they take a drug,” says Paul Clark, chief executive officer of Icos. “Cialis allows you to have a more spontaneous relationship.”

First Phase 3 Data Show Cialis Improved Sexual Function in Men With Difficult to Treat, Diabetes-related ED

Wednesday, July 16th, 2008

The first Phase 3 study for Cialis, a new PDE5 inhibitor being developed by Lilly ICOS LLC to treat erectile dysfunction (ED), showed strong results among one of the most difficult to treat populations of men with ED. The findings–to be released tomorrow at the European Association of Urology Meeting (EAU)–demonstrated that 64 percent of men with diabetes-related impotence taking Cialis 20 mg on demand reported improved erections.

“The impairment of nerve and blood vessel function that accompanies diabetes makes ED prevalent and particularly difficult to treat in this population,” said Professor Inigo Saenz de Tejada, of the Foundation for Research and Development in Andrology in Madrid, Spain. “This study, alongside previously released data, suggests on demand Cialis may help most men with impotence regain sexual function, regardless of cause or severity.” Tejada noted that while direct comparisons cannot be made to the clinical trial results of other ED compounds in patients with diabetes, the 74 percent response rate seen in this Cialis study is impressive.

Sexual function or enhanced erections significantly improved across all study endpoints

In this Phase 3 study, 216 men with mild-to-severe diabetes-related impotence were randomized to receive either placebo or Cialis at doses of up to 20 mg for 12 weeks. Results indicated 74 percent of men taking Cialis 20 mg reported improved erections, compared to 25 percent for placebo. Treatment with Cialis significantly improved sexual function compared to placebo across all primary and secondary study endpoints, regardless of patient age, duration and severity of impotence or diabetes.

Importantly, study participants reflected a broad cross-section of men with diabetes and included those with poor glucose control, diabetic retinopathy

(damage to the retina in the eyes), and diabetic kidney disease. Despite including men with these diabetes-related complications, few side effects were reported in this study. Headache and dyspepsia (indigestion) were the only side effects reported by greater than five percent of study participants. Researchers observed no significant changes in clinical laboratory values, ECGs (electrocardiograms) or blood pressure in this trial. In addition, Cialis use was not associated with disturbances in color vision for men in the study, including those with diabetic retinopathy. Of the side effects that were reported, the majority were mild-to-moderate and appeared to diminish with continued treatment. Few patients discontinued treatment due to side effects.

Additional results from the Cialis global Phase 3 program will be presented at scientific meetings later this year.

Phase 2: Up to 88 percent of men with ED of varying etiologies reported improvement

Findings from a Cialis Phase 2 study are also to be presented at this meeting. In this study, a broad population of impotence sufferers of varying severity and causes (including men with diabetes) took Cialis on demand at doses of up to 25 mg for eight weeks. Results indicated that up to 88 percent of men taking Cialis reported significantly improved erections, compared with 28 percent of those taking placebo. Headache and dyspepsia were the only side effects reported by greater than five percent of all Cialis-treated study participants.

Several measures of sexual function and satisfaction indicate Cialis superior to placebo

New Clinical Data Show Patients Receiving Cialis - tadalafil - Improved Intercourse Success at 24 and 36 Hours After Dosing

Monday, July 7th, 2008

According to newly released clinical data on Cialis,  PDE5 inhibitor developed by Lilly ICOS LLC for the treatment of erectile dysfunction (ED), men with ED reported a statistically significant improvement in successful intercourse attempts at 24 and 36 hours after taking the drug, compared to placebo.

These and other new findings - including a summary of cardiovascular safety data that showed no increased incidence of cardiovascular events during clinical studies - are being presented at the 97th Annual Meeting of the American Urological Association in Orlando, Florida.

Cialis Period of Effectiveness - Key Study Findings

In a Phase III clinical study designed to evaluate the efficacy of Cialis at specific time points after dosing, 348 men with mild-to-severe ED were randomly assigned to receive Cialis 20 mg (n=175) or placebo (n=173) over approximately an eight-week period. Patients were instructed to attempt intercourse with their partners on four specific occasions: on two occasions at 24 hours after dosing and on two occasions at 36 hours after dosing. The primary endpoint was the percentage of successful sexual intercourse attempts.

“Cialis was statistically superior to placebo in enabling men with ED to have successful intercourse at 24 or 36 hours after taking the drug and showed a consistent effect at both time points,” said Raymond Rosen, Ph.D., study author and director of the Program in Human Sexuality at the University of Medicine and Dentistry of New Jersey and professor of psychiatry, Robert Wood Johnson Medical School, Piscataway, New Jersey. “Also, in this study, the duration of effectiveness did not appear to influence the incidence or severity of side effects.”

In addition, study results show that in secondary measures of efficacy - including ability to penetrate, satisfaction with hardness of erection and overall satisfaction - Cialis was statistically superior to placebo at 24 and 36 hours.