Tuesday, January 29, 2008

FDA approves daily Cialis doses

NEW YORK (Reuters) - Eli Lilly and Co on Tuesday said U.S. regulators approved once-daily use of two low-dose forms of its Cialis anti-impotence drug, offering greater convenience for men expecting frequent sexual activity.

The Indianapolis drugmaker said the once-daily formulations, in dosages of 2.5 milligrams and 5 milligrams, will allow men to attempt sexual activity any time between 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," Lilly said in a release.

The low-dose daily formulations, already approved in parts of Europe, "may be most appropriate for men with erectile dysfunction who anticipate more frequent sexual activity (e.g. twice weekly)," Lilly said.

The company said the low-dose formulations provide "a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity."

The treatment, which has global annual sales of $1.2 billion, has been available in the United States since 2003 in dosages of 5 milligrams, 10 milligrams and 20 milligrams, and taken as needed. Those dosages provide effectiveness for up to 36 hours.

Company spokeswoman Keri McGrath said no dosage forms of the medicine, including the newly approved lower ones, are appropriate for heart patients who take nitrates, including nitroglycerin.

Members of the class of drugs to which Cialis belongs -- including Pfizer Inc's rival Viagra and GlaxoSmithKline Plc's Levitra -- can dangerously lower blood pressure when used alongside nitrates.

The drugs, used by millions of men worldwide, also carry new warnings about potential risk of sudden hearing loss.

Shares of Lilly were up $1.05, or 1.9 percent, to $55.60 in morning trading on the New York Stock Exchange, in line with a 2 percent advance for the drug sector.

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