The erectile dysfunction drug Cialis (tadalafil) has been approved by the Food and Drug Administration for once-daily use in 2.5-mg and 5-mg doses, the drug's manufacturer announced.
“This low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity,” according to a statement issued by Eli Lilly & Co. “For other men, Cialis taken as needed—the previously approved dosing regimen—may be most appropriate.”
Cialis was approved in 2003 in 5-mg, 10-mg, and 20-mg doses as the first and only phosphodiesterase type 5 inhibitor to provide sustained efficacy for up to 36 hours.
The approval of Cialis once daily is based on results from three phase III randomized, double-blind, placebo-controlled studies, which demonstrated that men with erectile dysfunction who took tadalafil 2.5 mg or 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function, compared with placebo, the statement said.
The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing, and pain in a limb. These side effects were transient.
FAMILY PRACTICE NEWS and “The Pink Sheet” are published by Elsevier.