(NaturalNews) The FDA has approved a once-a-day dose of Eli Lilly's erectile dysfunction drug Cialis, to allow patients round-the-clock erectile function without the need to plan for sexual activity ahead of time.
The 2.5 or 5 milligram doses of the drug "may be most appropriate for men with erectile dysfunction who anticipate more frequent sexual activity (e.g. twice weekly)," the company said in a press release. Once-a-day doses of Cialis have already been approved for use in Europe.
Cialis, known generically as tadalafil, was the third anti-impotence
drug to become available, following sildenafil (marketed by Pfizer as Viagra) and vardenafil (marketed by Glaxo SmithKline as Levitra). All three drugs are known to dangerously lower blood pressure when mixed with the nitrate medications, including nitroglycerine, that are often used in the treatment of heart disease. They also carry warning labels about the possibility of sudden and irreversible hearing loss.
Originally introduced in larger five-, 10- or 20-milligram doses intended to last 36 hours, Cialis earned the nickname "weekend pill." The new, lower dose is intended to be taken more regularly.
The lower dose provides "a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity,"
Eli Lilly said.
The FDA based its decision on the results of three randomized, double-blind placebo studies that showed the effectiveness of Cialis for 24 hours in the smaller doses.
"In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of
therapy," Eli Lilly said.
Cialis was originally developed by Eli Lilly in partnership with ICOS; Eli Lilly became sole owner when it purchased ICOS in 2006. Since its introduction in 2003, sales of the drug have reached $1.2 billion per year.
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