Healthcare Industry News: Adcirca
News Release - October 30, 2012
European Commission approves Cialis(R) (tadalafil) tablets for the treatment of the signs and symptoms of benign prostatic hyperplasiaCialis becomes only medication approved in the EU for both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia
INDIANAPOLIS, Oct. 30, 2012 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (LLY) announced today that the European Commission has approved Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Cialis was approved for erectile dysfunction (ED) in the EU in 2002. Cialis for once daily use was approved to treat ED in the EU in 2007.
"With this approval, Cialis is now the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a useful therapeutic option for men and physicians."
Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration (FDA) in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH).
In addition to the U.S. and EU, Cialis for once daily use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.
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. It also should not be taken by those who are 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 their healthcare provider or get help right away.
About ED and BPH
ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. Approximately 50 percent of men between 40-70 years old have ED.
BPH is a condition where the prostate enlarges, which can cause urinary symptoms. Common symptoms of BPH include:
- Needing to go frequently or urgently
- Stopping or starting during urination
- Needing to push or strain during urination
- Having a weak urine stream
- Incomplete emptying of the bladder
- Nocturia, or needing to go excessively at night
Cialis is currently approved for ED in more than 100 countries throughout the world.
In the United States, Cialis provides men with ED two different dosing options – Cialis for once daily use (2.5 mg and 5 mg) and Cialis for use as needed (5 mg, 10 mg and 20 mg). Cialis is not to be taken more than one time each day.
Cialis for once daily use is approved to treat ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions (ED+BPH). Cialis 5 mg for once daily use is the recommended dose to treat BPH and ED+BPH.
Cialis for once daily use can help men with ED be ready anytime between doses*, so they do not have to plan sexual activity around taking a pill. It can also treat the signs and symptoms of BPH. Cialis for once daily use is the only medication approved to treat both ED and the signs and symptoms of BPH.
Cialis for use as needed is approved to treat erectile dysfunction (ED). Cialis for use as needed should be taken before sexual activity. It may go to work quickly (in as little as 30 minutes in some men) and can work up to 36 hours.*+
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 two days.
*Individual results may vary. Not studied for multiple attempts per dose.
+ In clinical trials, Cialis for use as needed started to work in 30 minutes for some men who took 20 mg of Cialis for use as needed. When taken as needed, Cialis was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt.
About Eli Lilly and Company
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.
This press release contains forward-looking statements about the potential of Cialis for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that Cialis will receive additional regulatory approvals. There is also no guarantee that Cialis will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
 Feldman HA et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151(1):54-61.
 Rosen R, Altwein J, Boyle P, Roger SK, Lukacs B, Meuleman E, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003;44(6):637-649.
 Brookes ST, Link CL, Donovan JL, and McKinlay JB. Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey. J Urol 2008;179:250-255.
 Gacci M, et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2011; 60:809-825.
Source: Eli Lilly
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