FDA Approves Cialis to Treat Benign Prostatic Hyperplasia

November 3, 2011

For the person who asked...Cialis is NOT approved for hypertension but for BPH

October 6, 2011 -- The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which theprostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequenturination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.

In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

“BPH can have a big impact on a patient’s quality of life,” said Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men.”

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

Source: FDA

Posted: October 2011

-- Regards, VergelBook link

November 4, 2011

It will be interesting to see what Eli Lily does to Cialis pricing, now that

they have this approval for Cialis to treat BPH.

Just out of curiosity, I went to my pharmacy benefit company's website

(Caremark) to price a 30 day supply of Cialis 5mg. My insurance currently won't

cover it at all (this could change); I was surprised to see it was only about

$90 for 30 days, at Caremark's pricing. That's not totally out of the ballpark,

really, for BPH drugs. Some are cheaper, but some are a good bit pricier.

Eli could leave their pricing " as is " and they'll probably claim a huge market

share for BPH treatment. Many men with BPH would love the fringe benefit of a

boost against ED, even if they don't REALLY need the ED drug. Or, Eli Lily

could jack up the pricing, since they're the only BPH medication that works

against ED. This should be interesting to watch unfold. I'm betting on the

greed winning out.

>

> For the person who asked...Cialis is NOT approved for hypertension but for

> BPH

> FDA Approves Cialis to Treat Benign Prostatic Hyperplasia

> October 6, 2011 -- The U.S. Food and Drug Administration today approved

> Cialis <http://www.drugs.com/cialis.html> (tadalafil) to treat the signs

> and symptoms of benign prostatic hyperplasia (BPH), a condition in which the

>

prostate<http://www.drugs.com/newdrugs/fda-approves-cialis-benign-prostatic-hype\

rplasia-2890.html?utm_source=feedburner & utm_medium=feed & utm_campaign=Feed%3A+Dru\

gscom-NewDrugApprovals+%28Drugs.com+-+New+Drug+Approvals%29 & utm_content=Google+F\

eedfetcher#>

> gland

> becomes enlarged, and for the treatment of BPH and erectile dysfunction

> (ED), when the conditions occur simultaneously. Cialis was approved in 2003

> for the treatment of ED.

>

> Common symptoms of BPH include difficulty in starting urination and a weak

> urine stream; a sudden urge to urinate; and more

>

frequenturination<http://www.drugs.com/newdrugs/fda-approves-cialis-benign-prost\

atic-hyperplasia-2890.html?utm_source=feedburner & utm_medium=feed & utm_campaign=Fe\

ed%3A+Drugscom-NewDrugApprovals+%28Drugs.com+-+New+Drug+Approvals%29 & utm_content\

=Google+Feedfetcher?printable=1#>

> including

> at night.

> The severity of symptoms of BPH can be measured using the International

> Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who

> took 5 milligrams (mg) of Cialis once daily experienced a statistically

> significant improvement in their symptoms of BPH compared to men who were

> treated with placebo. The trials based their findings on a reduction in

> total IPSS scores.

> In a third study, men who experienced both ED and BPH and who took 5 mg of

> Cialis once daily had improvement in both their symptoms of BPH and in

> their ED compared to men who were treated with placebo. The improvement in

> ED was measured using the Erectile Function domain score of the

> International Index of Erectile Function.

> " BPH can have a big impact on a patient's quality of life, " said

> Monroe, director of the Division of Reproductive and Urologic Products in

> the FDA's Center for Drug Evaluation and Research. " A large number of older

> men have symptoms of BPH. Cialis offers these men another treatment option,

> particularly those who also have ED, which is also common in older men. "

> Cialis should not be used in patients taking nitrates, for example

> nitroglycerin, because the combination can cause an unsafe decrease in

> blood pressure. Also, the use of Cialis in combination with alpha blockers

> for the treatment of BPH is not recommended because the combination has not

> been adequately studied for the treatment of BPH, and there is a risk of

> lowering blood pressure.

> The FDA has approved eight other drugs to treat symptoms of BPH: Proscar,

> (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin),

> and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax

> (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

> Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

> Source: FDA

> Posted: October 2011

>

> --

> Regards,

>

> Vergel

> Book link <http://amzn.to/hCzxdA>

>

November 4, 2011