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Cialis(R) (tadalafil) for Once-a-Day Use Approved for the Treatment of Erectile Dysfunction by European Commission
Indianapolis (ots/PRNewswire) -
- Daily dosing option is first prescription oral treatment to offer uninterrupted management of erectile dysfunction in select men
Lilly (NYSE: LLY) announced today that the European Commission has granted marketing authorization for Cialis(R) (tadalafil)(1) 2.5 mg and 5 mg, an oral PDE5 inhibitor dosed once daily to treat erectile dysfunction (ED). The approval decision follows a positive opinion adopted April 26, 2007, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Lilly anticipates launch will begin in select countries during the second half of 2007 and continue throughout the EU in 2008.
Based on patient choice and physician assessment, tadalafil for once-a-day use is for patients who respond to PDE5 inhibitor therapy and who anticipate sexual activity at least twice weekly.(2)
The recommended dosing for tadalafil for once-a-day use for most patients is 5 mg daily. The dose may be decreased to 2.5 mg once a day based on individual tolerability.
Tadalafil 10 and 20 mg have been approved for as-needed (on-demand) treatment of ED in all member states of the European Union since November 2002. Tadalafil for once-a-day use is a daily regimen of this therapy.
"ED is typically a chronic disease and, for some men, Cialis for once-a-day use will eliminate the need to plan sex within a limited timeframe as they would with other therapies," said Abbas Hussain, president of European operations for Lilly. "The approval of Cialis for once-a-day use marks the first time an oral ED prescription-only medicine is available to provide some men with uninterrupted treatment for their ED."
The European Commission based its decision on the review and evaluation of the comprehensive data package for the daily-dosing option of tadalafil. The data include results from three phase III randomized, double-blind, placebo-controlled studies. In these clinical studies, men with ED taking tadalafil 2.5 mg and 5 mg once daily experienced improved erectile function compared with those taking placebo.
The most commonly reported adverse events are indigestion, back pain, muscle aches, facial flushing and nasal congestion. All adverse events reported with tadalafil were transient and generally mild or moderate.(3)
Tadalafil is approved for the treatment of ED and is currently available in more than 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. More than 10 million patients worldwide have been treated with tadalafil since its first introduction in February 2003. In Europe, tadalafil is available by prescription only and is taken as needed prior to sexual activity or in a daily regimen.
The most commonly reported adverse events with tadalafil on-demand are headache, upset stomach, nasal congestion, backache, muscle ache, dizziness and flushing. The adverse events reported with tadalafil were transient and generally mild or moderate. As with other PDE5 inhibitors, the use of tadalafil is contraindicated in patients who are taking nitrates, for those who have cardiac disease in whom sexual activity is not advisable, and for those patients with non-arteritic anterior ischemic optic neuropathy (NAION).
ED is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. As of 2004, it is estimated that approximately 189 million men worldwide will have ED.(4) Experts believe that 80 percent to 90 percent of ED cases are related to a physical or medical condition, such as diabetes, cardiovascular diseases, and prostate cancer treatment, while 10 percent to 20 percent are due to psychological causes.(5,6) In many cases, however, both psychological and physical factors contribute to the condition.(7)
Lilly, a leading innovation-driven corporation is developing a growing portfolio of first-in-class and best-in-class 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.
Certain of the matters discussed herein with respect to clinical studies and Lilly's products may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations, estimates and projections about the industry, management beliefs and certain assumptions made by management. Investors are cautioned that matters subject to forward-looking statements involve risks and uncertainties, including economic, competitive, governmental, technological and other factors discussed in the two companies' respective filings with the Securities and Exchange Commission, which may affect the business and prospects of the two companies. More specifically, there can be no assurance that this product will achieve commercial success or that competing products will not pre-empt any market opportunity that might exist for the product.
@@start.t1@@ (1) Cialis(R) is a registered trademark of Eli Lilly.
(2) Draft Summary of Product Characteristics, Data on file
(3) Annex II, section B, page. 37. Summary of Product Characteristics.
Data on file.
(4) Data were extrapolated from Feldman HA, Goldstein I, Hatzichristou
DG, Krane RJ. Impotence and its Medical and Psychosocial Correlates:
Results of the Massachusetts Male Aging Study, Journal of Urology.
Vol. 151, 54-61, January 1994 and World Population Projection Program
Of United Nations (2002 Revision) with indirect standardization.
(5) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(6) Diseases and Conditions: Impotence,
http://www.impotence.org/FAQ/index.asp. Data accessed 11/20/03.
(7) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.@@end@@
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