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The US Food and Drug Administration (FDA) approved Cialis in November 2003, but the drug’s history goes back to 1993.
At that time, a biotech company in the state of Washington began studying a phosphodiesterase type 5 (PDE-5) inhibitor they called IC351. After learning about another PDE-5 inhibitor called sildenafil that had the unusual side effect of helping men have stronger erections, the Washington scientists realized the potential IC351 could have in treating erectile dysfunction (ED). Phase 1 clinical trials of IC351 began in 1995. Phase 2 trials followed in 1997.
In 1998, ICOS, the company studying IC351, and Eli Lilly formed Lilly ICOS, LLC, a joint venture for further developing tadalafil (as IC351 was renamed) as a treatment for ED. By 2002, Lilly ICOS reported clinical trials showing that the drug was effective for up to 36 hours, and one year later, the drug was approved under the brand name Cialis. The drug’s long (17.5 hour) half-life became a primary marketing point, because the half-life of Viagra is only four hours.
Like Viagra and Levitra, Cialis became a blockbuster drug. In the fourth quarter of 2013, the drug was the 51st best-selling drug in the US, bringing in $280 million in that quarter alone. It was the fourth biggest seller for Lilly, behind only Cymbalta, Humalog, and Alimta. At that time, Viagra was ranked number 45 in terms of sales, bringing in $300 million that quarter.
Dosage for Cialis Taken on As Needed Basis
The typical starting dosage for Cialis is 5 mg to 20 mg, taken on an “as-needed” basis. The most common starting dose is 10 mg, and the drug is supposed to be taken 15 minutes to half an hour before anticipated sexual activity. One of the primary selling points of Cialis is that, unlike with Viagra and Levitra, men can be more flexible about timing sexual activity, since Cialis has such a long half-life. In fact, it has been successfully marketed as “the weekend pill” since effects can last up to 36 hours.
Sometimes “As Needed” Therapy Doesn’t Work Well
For some men, taking Cialis on an “as needed” basis doesn’t work so well. But with Cialis, there is an alternative to on-demand usage. Cialis can be taken once daily, usually at a dosage of 2.5 mg, and for some men, this type of regimen produces better results than only taking Cialis before anticipated sexual activity. Cialis is the only one of the “big three” ED medications for which daily low-dose therapy has been approved by the FDA.
Study of As Needed vs. Daily Cialis Therapy
In 2012, Dr. Edward Kim and his colleagues from the University of Tennessee Medical Center presented research at the World Meeting on Sexual Medicine about on-demand versus daily therapy with Cialis. Kim said that even at maximum dosage, some men simply don’t experience relief from ED when the drug is taken as needed.
Kim and his research team conducted two randomized, double-blind, controlled trials of daily Cialis therapy in 623 men with an average age of 58. The men in the study had not achieved good results using as needed dosing. They were randomly assigned to one of three groups: placebo, tadalafil 2.5 mg titrated to 5 mg, and tadalafil at a 5 mg dosage. The trial took place over 12 weeks. The men’s erectile functioning was evaluated using the International Index of Erectile Function (IIEF), a survey tool.
Men who took either dose of tadalafil reported significantly improved IIEF scores over the course of the study compared to men who took the placebo. IIEF scores of at least 26 were reported by 39% of men on the 2.5 mg to 5 mg titrated dose, by 40% of men taking 5 mg daily, but by only 12% of men taking the placebo. Men who took either dose of tadalafil had an average 8-point increase in IIEF scores by the end of the trial, while men taking a placebo only reported an average 2-point increase in IIEF score. Results of another monitoring tool, the Sexual Encounter Profile, showed significantly greater improvement for men who took tadalafil versus those who took the placebo.
Kim pointed out a couple of limitations of the study. For one thing, it did not include a consistent daily tadalafil dose of 2.5 mg. For another, the on-demand dosing period was only 4 weeks, while the daily therapy period was 12 weeks. Still, the researchers were encouraged by the results, stating that daily low dose therapy may be a good option for men with ED who don’t experience good results when taking the drug on demand.
Cialis and Benign Prostate Enlargement
While the recommended dosage for daily Cialis therapy is 2.5 mg or 5 mg, the drug may also be taken daily at a dosage of 5 mg to treat an entirely different problem than ED. Cialis is also approved for treatment of benign prostatic hyperplasia (BPH, or enlarged prostate). In October 2011, the FDA approved the use of Cialis for treating symptoms of BPH, which may include difficulty urinating, weakened urine flow, and inability to fully empty the bladder. Moreover, Cialis, typically at a 5 mg daily dose, is also FDA-approved for treatment of men who have both BPH and ED.
Conclusion
Cialis is one of the three best-selling drugs for ED, and has gained a loyal following due to its long lasting effects. Unlike Viagra and Levitra, Cialis is approved for on-demand usage as well as daily therapy, and is also approved for daily treatment of BPH, and of BPH and ED together. Men who do not get satisfactory results from taking Cialis on demand may find greater relief from ED by taking the drug daily at a low dosage.
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