The FDA extend their approval of Cialis

Two Versions of Drug

In January, 2008, Eli Lilly and Company announced a major step forward in the regulatory approval of Cialis (generic name: tadalafil) in the USA. Cialis is a PDE5 inhibitor used for the relief of erectile dysfunction (ED). For some time, there have been two versions of this drug and both have been sold in European markets.

The first is a longer acting version which enables a sexual response to be made for up to thirty-six hours. It is taken on an "as-needed" basis. In November, 2003, this was approved for use in the USA. When it was launched, Cialis transformed the market which had previously been dominated by Viagra. Cialis was and remains the only PDE5 inhibitor providing effective relief from ED for more than six hours (the current maximum periods of effectiveness achieved using either Viagra or Levitra).

The second version of Cialis is a low-dose version. This offers the men affected by ED the option of taking Cialis more frequently. The advantage of this second version is that men can have sexual intercourse more regularly once a daily routine is established. When the longer version is taken, the man who continues to suffer from ED has to carefully monitor time between each tablet to ensure that there is no overdose. It is possible that a man who loses track of time may find that the Cialis is no longer active in his system. This can be an embarrassment.

Cialis for once-daily use

On the 8th January, the Food and Drug Administration (FDA) approved Cialis for once-daily use at the dosages of 2.5mg and 5mg. This acknowledges the clear evidence from clinical trials that, once the daily routine is established, sexual activity may take place at any time between doses.

When asked for a statement, Shawn Heffern, Cialis U.S. Director of Brand Marketing at Lilly said, "We strive to provide patients with solutions that fit their needs and Cialis for once daily use delivers on this promise. Now, patients have two options:

1. some may prefer the up-to-36 hours of efficacy provided by Cialis for use as needed,
2. while others may want the unique benefit provided by this daily dosing option."

In financial terms, the FDA’s approval has boosted the share value of Eli Lilly by around $1.50 or 2.8%. It has since traded at over $56 per share. In terms of market share, Cialis is still catching up to Viagra (manufactured by Pfizer Inc.) In the first nine months of 2007, Viagra’s total declared sales were valued at $1.26bn, whereas Cialis “only” sold $798m during the same period.

Cialis posted full-year sales of $971m in 2006, a 30% improvement over 2005. It is therefore expected that Cialis will exceed $1bn sales for 2007 when final quarter figures are released. It seems likely that the FDA’s approval will significantly enhance the market momentum enjoyed by Cialis because even though both Viagra and Levitra can be taken daily, the FDA has only approved this dosage regimen for Cialis and not for Viagra and Levitra.

So, consult your doctor and enjoy the freedom to choose the treatment regimen that is right for you. To make sure that this is a free choice and not biased by pricing considerations, Eli Lilly has adjusted the wholesale price so that you should enjoy both treatments at the same cost assuming that you only used the longer lasting version twice a week. If you prefer spontaneity and do not want the hassle of counting the hours between tablets, the newly approved Cialis is for you.