FDA approves new ED drug dose for once-daily use

January 31, 2008

The FDA has approved a new lower-dose regimen of tadalafil (Cialis), an oral erectile dysfunction medication for once-daily use. The 2.5-mg formulation is intended for use by men with ED who anticipate sexual activity at least twice weekly. For other men, the previously approved 5-mg dosing regimen is indicated.

The FDA has approved a new lower-dose regimen of tadalafil (Cialis), an oral erectile dysfunction medication for once-daily use. The 2.5-mg formulation is intended for use by men with ED who anticipate sexual activity at least twice weekly. For other men, the previously approved 5-mg dosing regimen is indicated.

When tadalafil is taken daily, men can attempt sexual activity at any time between doses. In clinical trials, when taken without restrictions on the timing of sexual activity, the lower dose of the drug taken once daily improved erectile function over the course of therapy.

Most adverse events reported with tadalafil were transient and generally mild or moderate.