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FDA Approves Cialis(R) (tadalafil) For Once Daily Use For The Treatment Of Erectile Dysfunction
Eli Lilly and Company
(NYSE: LLY) announced that the U.S. Food and Drug Administration
(FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and
5 mg), an oral medication taken once per day to treat erectile dysfunction
(ED). When Cialis for once daily use is taken daily, men can attempt sexual
activity at anytime between doses.
Currently available in parts of Europe, this low-dose daily treatment
option of Cialis may be most appropriate for men with ED who anticipate
more frequent sexual activity (e.g. twice weekly). For other men, Cialis
taken as needed - the previously approved dosing regimen - may be most
appropriate.
In clinical trials, when taken without restrictions on the timing of
sexual activity, Cialis for once daily use improved erectile function over
the course of therapy.
"ED can be a chronic condition like diabetes or high blood pressure,"
said Ridwan Shabsigh, M.D., Director of the Division of Urology at
Maimonides Medical Center in New York. "As a urologist, I know couples like
to have choices and will appreciate the availability of Cialis for once
daily use."
Cialis for use as needed transformed the U.S. ED market when it was
approved in 2003 as the first and only PDE5 inhibitor clinically proven to
provide sustained efficacy for up to 36 hours. Cialis for once daily use
provides a new option for men who may be looking for a dosing option that
can be taken without regard to timing of sexual activity. In consultation
with their physician, patients now have the freedom to choose the dosing
regimen that is appropriate for them.
"We strive to provide patients with solutions that fit their needs and
Cialis for once daily use delivers on this promise," said Shawn Heffern,
Cialis U.S. Director of Brand Marketing at Lilly. "Now, patients have two
options - some may prefer the up to 36 hours of efficacy provided by Cialis
for use as needed while others may want the unique benefit provided by this
daily dosing option."
Additionally, Lilly's wholesale pricing for Cialis for once daily use
will be comparable to Cialis for use as needed such that patients who
currently use two or more pills per week of Cialis for use as needed should
not experience higher treatment costs with Cialis for once daily use.
The FDA's approval of Cialis for once daily use was based upon the
evaluation of the comprehensive data package for the daily dosing option.
The data include results from three phase III randomized, double-blind,
placebo- controlled studies. Men with ED who participated in these clinical
studies and who took tadalafil 2.5 mg and 5 mg once daily without regard to
their timing of sexual activity experienced improved erectile function
compared with those taking placebo.(2) Cialis 5 mg, 10 mg and 20 mg have
been approved in the United States for as-needed treatment of ED since
November 2003.
The most commonly reported adverse events were headache, indigestion,
back pain, muscle aches, nasal congestion, flushing and pain in limb. Most
adverse events reported with tadalafil were transient and generally mild or
moderate.
About ED
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. 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 predominantly due to psychological
causes.(3,4) In many cases, however, both psychological and physical
factors contribute to the condition.(5)
About Cialisz
Cialis(R) (tadalafil) is approved for the treatment of erectile
dysfunction on an as-needed basis or in a daily regimen. The recommended
starting dose of Cialis for use as needed in most patients is 10 mg, taken
prior to anticipated sexual activity. The dose may be increased to 20 mg or
decreased to 5 mg, based on individual efficacy and tolerability. As part
of a daily regimen, Cialis may be taken as 2.5 mg or increased to 5 mg,
based on individual efficacy and tolerability.
Important Safety Information for Cialis
Cialis is available by prescription only and is not for everyone. Men
should discuss their medical conditions and all medications with their
doctors to ensure Cialis is right for them and that they are healthy enough
for sexual activity. Men taking nitrates, often used for chest pain, should
not take Cialis. Such a combination could cause a sudden, unsafe drop in
blood pressure. Cialis for once daily use provides continuous plasma
tadalafil levels which should be considered when evaluating the potential
for interactions with certain medications (e.g., nitrates, alpha-blockers,
anti- hypertensives and potent inhibitors of CYP3A4) and with substantial
amounts of alcohol. The most common side effects with Cialis were headache,
upset stomach, delayed backache or muscle ache.
As with any ED tablet, in the rare event of priapism (an erection
lasting more than four hours), men should seek immediate medical attention
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
a man has a sudden decrease or loss of vision or hearing, he should stop
taking any ED tablet and seek medical attention right away.
Cialis does not protect a man or his partner from sexually transmitted
diseases, including HIV. Men should not drink alcohol in excess with
Cialis. Individual results may vary. Cialis has not been studied for
multiple attempts per dose.
Individual results may vary. Cialis has not been studied for multiple
attempts per dose. For full patient information and/or full prescribing
information, visit http://www.cialis.com.
About Eli Lilly and Company
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 world-wide 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. Additional
information about Lilly is available at http://www.lilly.com. P-LLY
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 respective filings with the Securities
and Exchange Commission, which may affect the business and prospects of
Lilly. 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.
References
(1) Cialis is a registered trademark of Eli Lilly.
(2) Cialis prescribing information, updated January 2008.
(3) Shabsigh, R. (2002). Back To Great Sex: Overcome ED and Reclaim Lost
Intimacy. New York: Kensington.
(4) Erectile Dysfunction,
http://kidney.niddk.nih.gov/kudiseases/pubs/impotence. Data accessed
09/28/07.
(5) Lue, Tom F. Erectile Dysfunction. N Engl J Med 2000; 342: 1802-1813.
Eli Lilly and Company
http://www.lilly.com
View drug information on Cialis.
FDA aprobã Cialis (R) (tadalafil), o datã pe zi Pentru utilizare pentru tratamentul disfuncþie erectilã - FDA Approves Cialis(R) (tadalafil) For Once Daily Use For The Treatment Of Erectile Dysfunction - articole medicale engleza - startsanatate