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Nineteen ninety-eight marked the beginning of an era in the treatment of erectile dysfunction (ED).
Little did pharmaceutical companies know, however, that the so-called PDE-5 inhibitors Viagra, Levitra, and Cialis would not only revolutionize ED treatment, but would also lead to a range of investigations of how these compounds address a host of other physiological conditions.
Viagra was the first of the PDE-5 inhibitors to be approved for treatment of ED, on March 27, 1998. Levitra was approved by the FDA in August 2003, and Cialis was given the FDA green light in November 2003. Today, Cialis ranks 42nd in the United States in terms of prescription drug sales, with $1.05 billion in sales for 2012. By prescription volume, Cialis ranks 21, having been prescribed almost 7.5 million times in 2012. Worldwide, Cialis posted sales of $1.93 billion in 2012.
Discovery of Cialis
In 1993, a biotech company called ICOS started studying a compound they called IC351, a PDE-5 inhibitor. In 1994, Pfizer discovered that a PDE-5 inhibitor they were studying called sildenafil had the interesting side effect of improving erections in men who were taking it in a clinical study of the drug for treating heart problems. ICOS patented IC351 in 1994 and started clinical trials in 1995, and the results were encouraging. In 1998, ICOS and Eli Lilly created a joint venture to further develop IC351, which they now called tadalafil, as a treatment for ED.
A May 2002 report by Lilly ICOS showed that tadalafil was effective in improving erections for up to 36 hours, and in 2003 the drug was approved by the FDA for that purpose. The advantage that Cialis had over the competition was its long half-life. Cialis could work for up to 36 hours, as opposed to 4 to 6 hours for competitors Viagra and Levitra. The drug was first available in dosages of 5, 10, and 20 mg, but by the end of 2008, the FDA approved the sale of Cialis as a once-daily treatment for ED at a dosage of 2.5 mg.
Cialis Approved for Treatment of BPH Symptoms
In 2011, the FDA approved Cialis for treatment of the symptoms of a condition called benign prostatic hyperplasia (BPH), which is a condition where the prostate gland enlarges, hindering the flow of urine. Both BPH and ED occur more frequently as men get older, and the FDA approval also covered the treatment of BPH and ED for men who experience both conditions.
In October 2013, the FDA approved another label change for Cialis after studies showed that once-daily use of Cialis at a dosage of 5 mg, combined with the drug finasteride, which is also used to treat BPH, significantly accelerated relief of BPH symptoms. Cialis plus finasteride provided BPH symptom relief in as little as 4 weeks, whereas finasteride given with a placebo took around 26 weeks (6 months) to provide relief from symptoms.
Cialis Milestones
An estimated 41 million people worldwide have taken Cialis, and though it wasn’t first to market in many places, it is still wildly popular, and offers men another choice for treating ED. By 2005, Cialis officially obtained “blockbuster” drug status, by reaching worldwide sales of $1 billion, and is today the most prescribed oral treatment for ED by urologists. The once-daily dosing regimen, as well as results that can last up to 36 hours have made Cialis the choice of men who need treatment for ED, but also want to preserve spontaneity in their sexual activity. The use of Cialis for treatment of BPH – another common problem as men age – is yet another reason for the drug’s continuing popularity.
Cialis has been part of a global change in how people understand and deal with ED. Before the advent of the PDE-5 inhibitors, ED was rarely discussed, and less was understood about the condition. Today, ads for ED drugs like Cialis are commonplace, and the topic of ED is much less of a taboo. Acceptance of ED as a physiological problem has made it easier for men to bring up the subject with their physicians and their partners, and treatment of ED with drugs like Cialis has improved the quality of life for millions of men and their partners worldwide.
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