Cialis® (tadalafil) marks 10 years since U.S. approval

Blockbuster drug has treated an estimated 41 million patients around the globe

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Nov 19, 2013, 08:00 ET

INDIANAPOLIS, Nov. 18, 2013 /PRNewswire/ -- Cialis is turning 10. As Cialis marks its 10^th anniversary this week, Lilly is looking back on the last decade in men's health.

Conversations that used to be taboo for men are now taking place in bedrooms and exam rooms. Men with conditions like erectile dysfunction (ED) are talking more openly with their partners and their physicians.¹ Part of this evolution was the U.S. approval of Cialis for use as needed (5 mg, 10 mg, and 20 mg) on November 21, 2003, as the first and only oral ED medication that can work for up to 36 hours.* In the time since, Cialis has grown to become global share-of-market leader in sales among PDE5 inhibitors.²

"Witnessing the evolution of Cialis since it entered the market 10 years ago, and the positive effects it continues to have on the treatment of erectile dysfunction, has been exciting," said Dr. Edward Kim, urologist, The University of Tennessee Medical Center. "Many of my patients have commented that the 36-hour dose and the daily dosing option have enabled them to become intimate without worrying about timing sexual activity around taking a pill. As an investigator and prescribing physician, I have been fortunate to participate, first-hand, in the evolution and development of this noteworthy pill for the treatment of ED."

It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain; or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure.

Since that first FDA approval, Cialis has been approved for once-daily use (2.5, 5 mg,) for ED, and for the signs and symptoms of benign prostatic hyperplasia (BPH), offering men the first and only single treatment option for two common urological conditions – ED and the signs and symptoms of BPH (Cialis 5 mg for once daily use).

Though Cialis was not the first to market in many countries, it has delivered global success and shown the importance of offering men a choice in their ED treatment.

TIME Magazine included Cialis on its list of Best Inventions of 2003.
Cialis obtained "blockbuster status" in 2005, when it reached $1 billion USD in worldwide sales.
In 2008, Cialis was approved in the U.S. for once-daily use, giving men two different dosing options to treat ED.
In 2011, Cialis was the first and only medication approved to treat both ED and the signs and symptoms of benign prostatic hyperplasia (ED+BPH).
To date, Cialis has treated an estimated 41 million patients around the globe.
Cialis is the most prescribed oral ED treatment by Urologists.
For the full year of 2012, worldwide Cialis sales increased 3 percent to $1.9 billion. U.S. Cialis sales for 2012 were $782 million, an 11 percent increase.³
Over 2.5 million prescriptions have been filled through the Promise Program, with approximately 1.5 million for Cialis for once daily use. The Cialis Promise Program provides men with ED an opportunity to try Cialis for free, as prescribed by their doctor.
Cialis is covered on many major health plans, and more than 114 million lives have commercial formulary access to Cialis for once daily use with a correct quantity limit of 30 tablets per 30 days.

"Men with ED tell us that they value a treatment option that allows them to respond when the moment is right. With 36-hour Cialis and Cialis for daily use, men have the flexibility they are looking for," said Debra Hussain, Cialis senior marketing director. "Cialis is also the only FDA-approved medication clinically proven to treat erectile dysfunction and the signs and symptoms of BPH—two common and related conditions in men. All of these indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health."

Cialis should not be taken by anyone who is allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.

Lilly has many reasons to applaud Cialis on its 10^th anniversary, and is looking forward to even more success with Cialis for years to come.

About Cialis
Cialis is indicated for the treatment of men with erectile dysfunction (ED), men with the signs and symptoms of benign prostatic hyperplasia (BPH), and men with both ED and the signs and symptoms of BPH. If Cialis is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks.

Cialis is not for women or children.

It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.

Important Safety Information for Cialis^® (tadalafil) tablets

What Is The Most Important Information I Should Know About Cialis?

Do not take Cialis if you:

take medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain as the combination may cause an unsafe drop in blood pressure
use recreational drugs called "poppers" like amyl nitrite and butyl nitrite
are allergic to Cialis or Adcirca^® (tadalafil), or any of its ingredients. Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing

After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

What Should I Tell My Healthcare Provider Before Taking Cialis?

Cialis is not right for everyone. Only your healthcare provider and you can decide if Cialis is right for you. Ask your healthcare provider if your heart is healthy enough for you to have sexual activity. You should not take Cialis if your healthcare provider has told you not to have sexual activity because of your health problems. Before taking Cialis, tell your healthcare provider about all your medical problems, particularly if you have or ever had:

heart problems such as chest pain (angina), heart failure, irregular heartbeats, or have had a heart attack
high or low blood pressure or have high blood pressure that is not controlled
stroke
liver or kidney problems or require dialysis
retinitis pigmentosa, a rare genetic (runs in families) eye disease
severe vision loss, including a condition called NAION
stomach ulcers or a bleeding problem
a deformed penis shape or Peyronie's disease
an erection that lasted more than 4 hours
blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect Cialis?

Tell your healthcare provider about all the medicines you take especially if you take:

medicines called "nitrates" which are often prescribed for chest pain
alpha-blockers often prescribed for prostate problems
blood pressure medications
medicines for HIV or some types of oral antifungal medications
some types of antibiotics such as clarithromycin, telithromycin, erythromycin (several brand names exist, please contact your healthcare provider to determine if you are taking this medicine)
other medicines or treatments for erectile dysfunction (ED)
Cialis is also marketed as Adcirca for the treatment of pulmonary arterial hypertension. Do not take both Cialis and Adcirca. Do not take sildenafil citrate (Revatio^®)** with Cialis.

What Should I Avoid While Taking Cialis?

Do not use other ED medicines or ED treatments while taking Cialis.
Do not drink too much alcohol when taking Cialis (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What Are The Possible Side Effects Of Cialis?

The most common side effects with Cialis are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking Cialis. Back pain and muscle aches usually go away within 2 days. Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon but serious side effects include:

An erection that won't go away: If you get an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

In rare instances, men taking prescription ED tablets, including Cialis, reported a sudden decrease or loss of vision or hearing (sometimes with ringing in the ears and dizziness). It's not possible to determine if these events are related directly to the ED tablets or to other factors. If you have a sudden decrease or loss of vision or hearing, stop taking any ED tablet, including Cialis and call a healthcare provider right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Cialis does not:

cure ED
increase a man's sexual desire
protect a man or his partner from sexually transmitted diseases, including HIV
serve as a male form of birth control

Cialis is available by prescription only. For additional information, talk to your doctor and see full Patient Information at http://pi.lilly.com/us/cialis-ppi.pdf and Prescribing Information at http://pi.lilly.com/us/cialis-pi.pdf, or visit www.cialis.com for more information.

* Individual results may vary. Not studied for multiple attempts per dose. In clinical trials, Cialis 20 mg for use as needed was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt.

** The brand listed is a trademark of its respective owner and is not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

TD Con-F ISI 03FEB2012

About Eli Lilly and Company (NYSE:LLY)
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.

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¹ Myers, et al. Direct-to-consumer advertising: exposure, behavior, and policy implications. Journal of Public Policy & Marketing: Spring 2011, Vol. 30, No. 1, pp. 110-118.

² IMS Health, IMS MIDAS, Jan 2012-July 2013. Worldwide share of market is calculated in USD among phosphodiesterase type 5 (PDE-5) inhibitors for erectile dysfunction (ED) from countries in the IMS MIDAS database: Australia, Austria, Belgium, Canada, Czech Republic, China Hospital, France, Germany, Greece, Italy, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, UK, China, Korea, Mexico, South Africa, Venezuela, Japan, US. Sales in these countries comprise more than 90% of worldwide sales of PDE5s for ED.