Erectile dysfunction medicine.

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 drug, offering greater convenience for
men expecting frequent sexual activity.

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The 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
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 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 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.

(Reporting by Ransdell Pierson, editing by Gerald E.
McCormick)