FDA Approves Addition to CIALIS® (tadalafil) Product Label
Study Data Shows Cialis 5 mg Initiated with Finasteride Provides Significantly
Greater Improvements in Urinary Symptoms of Benign Prostatic Hyperplasia than
Placebo with Finasteride
INDIANAPOLIS, Oct. 25, 2013
INDIANAPOLIS, Oct. 25, 2013 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY)
today announced the U.S. Food and Drug Administration (FDA) approved a product
label addition for CIALIS to include data from a 26-week study that showed
CIALIS 5 mg for once daily use started in combination with finasteride
significantly improved the signs and symptoms of benign prostatic hyperplasia
(BPH) as early as 4 weeks, compared to placebo with finasteride, in men with
BPH and an enlarged prostate. The combination of CIALIS and finasteride
initiated for BPH therapy is recommended for up to 26 weeks because the
incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the
incremental benefit of CIALIS beyond 26 weeks is unknown.
CIALIS is approved by the FDA to treat erectile dysfunction (ED), the signs
and symptoms of BPH, and both ED and the signs and symptoms of BPH (ED+BPH).
Finasteride is a type II 5 alpha-reductase inhibitor (5-ARI) approved by the
FDA for the treatment of BPH in men with an enlarged prostate.
"Urinary symptom improvement with 5-ARI therapy can take 6 to 12 months," said
Claus Roehrborn, MD, chairman, Department of Urology, The University of Texas
Southwestern Medical Center. "These data demonstrate that the combination of
CIALIS 5 mg for once daily use with finasteride leads to symptom improvement
as early as four weeks in men with BPH and an enlarged prostate. This means
that CIALIS 5 mg for once daily use can be an effective option for early
symptom relief when started in combination with finasteride."
The primary endpoint of the study - changes in total International Prostate
Symptom Score (IPSS) at 12 weeks - demonstrated that symptom improvement in
patients starting BPH treatment with CIALIS 5 mg for once daily use and
finasteride was greater than those starting with placebo and finasteride (-5.2
vs. -3.8; P = .001). Key secondary endpoints demonstrated that improvements in
IPSS occurred at the first scheduled observation at week 4 (-4.0 vs. -2.3; P<
.001) and continued through week 26.
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
In a subgroup of patients with BPH who were also sexually active and had ED at
baseline, CIALIS initiated with finasteride significantly improved erectile
function, as measured by the International Index of Erectile
Dysfunction–Erectile Function Domain, compared to placebo with finasteride.
These results were evident at 4 weeks (3.7 vs. -1.1; P< .001), 12 weeks (4.7
vs. 0.6; P< .001) and 26 weeks (4.7 vs. 0.0; P< .001).
About the Study
The randomized, double-blind, placebo-controlled, 26-week trial assessed the
efficacy and safety of CIALIS 5 mg for once daily use or placebo
co-administered with finasteride 5 mg in 696 men aged 45 years and older (mean
age 64) with an IPSS of at least 13, a urine flow rate (Qmax) of 4 millimeters
per second (mL/sec) to 15 mL/sec and a prostate volume at least 30 mL. The
study was conducted at 70 sites in 13 countries.
The primary measure was the IPSS, a questionnaire evaluating lower urinary
tract symptoms occurring during the preceding month where lower scores
indicate less severe symptoms. The pre-specified secondary measure was the
International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a
questionnaire evaluating erectile function where higher scores indicate better
Results from the Phase 3b study – Study H6D-CR-LVIW – have been accepted for
publication in The Journal of Urology and are available now online at
About BPH and ED
Benign prostatic hyperplasia (BPH) is a condition where the prostate enlarges,
which can cause urinary symptoms like needing to go urgently and frequently.
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.
BPH and ED are conditions that may occur in the same patient. Several studies
have shown that many men with ED also experience the symptoms of
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. CIALIS is not for women or
children. If CIALIS is used with finasteride to initiate BPH treatment, such
use is recommended for up to 26 weeks.
Important Safety Information for CIALIS^® (tadalafil) tablets
What Is The Most Important Information I Should Know About CIALIS?
Do not take CIALIS if you:
otake 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
ouse recreational drugs called "poppers" like amyl nitrite and butyl
oare 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
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
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:
oheart problems such as chest pain (angina), heart failure, irregular
heartbeats, or have had a heart attack
ohigh or low blood pressure or have high blood pressure that is not
oliver or kidney problems or require dialysis
oretinitis pigmentosa, a rare genetic (runs in families) eye disease
osevere vision loss, including a condition called NAION
ostomach ulcers or a bleeding problem
oa deformed penis shape or Peyronie's disease
oan erection that lasted more than 4 hours
oblood cell problems such as sickle cell anemia, multiple myeloma, or
Can Other Medicines Affect CIALIS?
Tell your healthcare provider about all the medicines you take especially if
omedicines called "nitrates" which are often prescribed for chest pain
oalpha-blockers often prescribed for prostate problems
oblood pressure medications
omedicines for HIV or some types of oral antifungal medications
osome 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)
oother medicines or treatments for erectile dysfunction (ED)
oCIALIS 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?
oDo not use other ED medicines or ED treatments while taking CIALIS.
oDo 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:
oincrease a man's sexual desire
oprotect a man or his partner from sexually transmitted diseases, including
oserve 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
* 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
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
This press release contains forward-looking statements about the use of Cialis
for the treatment of BPH and reflects Lilly's current beliefs. However, as
with any pharmaceutical product under development, there are substantial risks
and uncertainties in the process of development, commercialization, and
regulatory review. There is no guarantee that the product will receive
additional regulatory approvals. There is also no guarantee that the product
will continue to be commercially successful. For further discussion of these
and other risks and uncertainties, see Lilly's filings with theUnited States
Securities and Exchange Commission. Lilly undertakes no duty to update
 Casabe, A., Roehrborn, C.G., Da Pozzo, L.F., Zepeda, S., Henderson, R.J.,
Sorsaburu, S., Henneges, C., Wong, D.G., Viktrup, L. Efficacy and safety of
the co-administration of tadalafil once daily with finasteride for 6 months: a
randomized, double-blind, placebo-controlled study in men with lower urinary
tract symptoms and prostatic enlargement secondary to benign prostatic
hyperplasia. The Journal of Urology. 2013; doi:10.1016/j.juro.2013.09.059.
 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. In press. Eur Urol 2011; doi:10.1016/j.eururo.2011.06.037.
Refer to: Kelly Hoffman, 317-631-6400 (office), 317-459-7826 (mobile),
Morry Smulevitz, 317-651-5567 (office), 317-457-3294 (mobile),
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
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