Eli Lilly & Co. announced that the U.S. Food and Drug Administration (FDA) has approved Cialis (tadalafil) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses.
Currently available in parts of Europe, this low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly). For other men, Cialis taken as needed – the previously approved dosing regimen – may be most appropriate.
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.
“ED can be a chronic condition like diabetes or high blood pressure,” said Ridwan Shabsigh, M.D., Director of the Division of Urology at
Cialis for use as needed transformed the U.S. ED market when it was approved in 2003 as the first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Cialis for once daily use 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. In consultation with their physician, patients now have the freedom to choose the dosing regimen that is appropriate for them.
“We strive to provide patients with solutions that fit their needs and Cialis for once daily use delivers on this promise,” said Shawn Heffern, Cialis U.S. Director of Brand Marketing at Lilly. “Now, patients have two options – some may prefer the up to 36 hours of efficacy provided by Cialis for use as needed while others may want the unique benefit provided by this daily dosing option.”
Additionally, Lilly’s wholesale pricing for Cialis for once daily use will be comparable to Cialis for use as needed such that patients who currently use two or more pills per week of Cialis for use as needed should not experience higher treatment costs with Cialis for once daily use.
The most commonly reported adverse events in clinical studies were headache, indigestion, back pain, muscle aches, nasal congestion, flushing and pain in limb. Most adverse events reported with tadalafil were transient and generally mild or moderate.
Experts believe that 80-90% of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10-20% are predominantly due to psychological causes. In many cases, however, both psychological and physical factors contribute to the condition.
The recommended starting dose of Cialis for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. As part of a daily regimen, Cialis may be taken as 2.5 mg or increased to 5 mg, based on individual efficacy and tolerability.
