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NSP, Libigel is more then just a treatment

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Just the facts maam Member Profile Just the facts maam  
Saturday, June 09, 2012 5:28:15 PM
Re: NSP post# 16604 Post # of 25785 
NSP, Libigel is more then just a treatment for HSDD.

The Bloom efficacy trials where Libigel failed to meet endpoints was due to the placebo effect. Libigel acted expected the placebo was off the charts compared to historical placebo results.

Unlike many new drugs Libigel has the benefit of P&G Intrinsa approved. They passed an FDA voted 14-3 in favor of Intrinsa's efficacy but wanted further safety trials. P&G balked and went to Europe and got approved.

Keep in mind that the women in the Intrinsa trial wee on estrogen as well.

Libigel uses the same testosterone dosage as Intrinsa.

Refer to FDA tracker they lay it out pretty good.

Now, the second item is testosterone replacement therapy which is truly the primary market Biosante is after. To replace the more then 4 million off-label prescriptions being written annually. There is no approved female testosterone drug in the US. Trials showed that Libigel restores testosterone to pre-menopausal levels. Placebo doesn't move the needle.

Look at Market data for more info on Libigel.

Now finally one thing you won't see in the market data is that during the safety trial (which P&G did not do) Biosante discovered that Libigel (testosterone) reduces the risk of Cardiovascular events by approx. 70%. Biosante presently has two patent applications for the CV benefit and a patent application n the commercial production of Libigel none of this has been made public in a release.

In addition, the safety trial had an HSSD efficacy component and is set up a little differently, including allowing women with estrogen. This efficacy testing one was more in-line with the Intrinsa trial.

Basically there is a lot of ammo still make an 505(2)(b) NDA submission for one or more treatments. Worse case scenario they do a slightly different efficacy trial to prove HSSD. But the testosterone treatment should go ahead as planned.

Finally you may wish to read the following release where "Dr. Shames stated that the FDA acknowledges testosterone’s efficacy in treating HSDD and the need for testosterone products to be approved for women affected by this condition."

PR

Bottom line, it was always about safety.


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