Indevus Pharmaceuticals: Nebido Has Lost Its Libido 13 comments
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Once again, the FDA’s actions have left me dumbfounded. It has imposed a potential company- destroying two-year approval delay on Indevus Pharmaceutical's (IDEV) lead product Nebido. Indevus' stock price has plunged 70% to an multi-year low of $1.19/share.
Nebido is a Bayer (BAYRY.PK) originated drug that is a long-acting preparation of testosterone that is used for replacement therapy for men with low levels of testosterone.
Low levels of testosterone increase with age and are a largely underreported and misdiagnosed condition. Low testosterone causes a constellation of symptoms including decreased sex drive or loss of libido, impotence, low muscle mass, increased fat mass, depression, fatigue, and a general decline in the general feel of well being.
In the United States, 38% of men at least 45 years old who visited a primary care doctor were found to have had hypogonadism or low testosterone levels. This represents a significant number of potential individuals who can benefit from hormonal replacement therapy.
Since there are 50 million men in America who are 45 or older, at a 38% prevalence rate of low testosterone, there are up to 17 million patients who could benefit from Nebido. Remarkably, only 1.3 million of those men are being treated.
While many patients rely on daily applications of testosterone cream, or biweekly intramuscular injections of testosterone, they suffer from a sawtooth pattern of testosterone concentrations leading to a fluctuation of symptom relief. Nebido avoids this with 12-weekly injections (once every 12 weeks), after physiological maintenance levels of serum testosterone are attained.
Nebido is the first and only long-acting testosterone preparation available in the U.S.
Why did the FDA significantly protract Nebido’s approval review date? It comes down to a few isolated cases of transient reversible shortness of breath and coughing following an injection.
In the U.S. clinical trials, which included a total of approximately 500 patients, there was a single instance of this phenomenon with the 750 mg (3ml) dosage of Nebido. The patient did not require medical intervention and the event resolved within 10 minutes. In Germany, there were some reports of the same phenomenon with the larger volume (4ml) 1000 mg dosage of Nebido.
Mind you, these were not results from German clinical trials. Instead, they are from post-marketing adverse reports that occurred (rarely) in Germany. The most serious side effects were even rarer: flushing, dizziness and fainting. There were no permanent injuries reported.
Most importantly, these adverse reactions were most likely not due to any pharmaceutical shortcomings inherent in the drug itself. Instead, they appear to be a result of improper injection of the drug itself resulting in venous absorption of the drug.
Once more, why would the FDA impose a two-year delay on a proven pharmaceutical product? Does the FDA know something the European Medicines Agency [EMEA] doesn’t?
Apparently not, since its the EMEA’s own data the FDA is relying on.
After all, Nebido has been in Europe since 2003, when it was originally approved in Finland and later in 2005, it was approved by a European mutual recognition procedure for the rest of Europe.
So, what is the problem? The problem is not with Nebido. The problem is with the FDA itself.
The FDA’s regulatory authority was perceived to be somewhat impotent following the Vioxx disclosures of repeated incidences of ignored signs of cardiovascular side effects. Likewise, the perception of FDA’s integrity was less than magic following the Provenge fiasco, where there were well-substantiated claims of conflicts of interests of FDA panelists involved in the delay of its approval. Assumedly, these shortcomings made the FDA act more aggressively- particularly following the recent humiliating congressional hearings.
But these FDA inadequacies did not give the FDA the right to sodomize Nebido’s chances of approval. Disgusting, isn’t it?
Disclosure: none
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This article has 13 comments:
Seriously, what else could it be? I'm 66 yrs old and wish there was something available to deter the muscle loss I'm experiencing form low testosterone.
I'm waiting for the CEO of IDEV to make a comment on this.
I do hold stock in IDEV.
The FDA, by design, exercises extreme caution with respect to their evaluation and approval of drugs since the health of every American is potentially at risk. Additionally, their judgment is devoid of the commercial zeal that investors have about a particular product. If we had to shoulder the responsibility of evaluating a drug and observing the consequences of prematurely approving a drug that should have had a more rigorous screening, I truly believe that most would err on the side of caution.
There are presently testosterone products that are available that are delivered through safer delivery systems (i.e. transdermally). What I would be more concerned with is the potential that androgen therapy has for increased risk of benign enlargement of the prostate or that it may promote the growth of existing cancer of the prostate. However, the once every three month injectable regimen does confer a patient-centric advantage in terms of convenience.
Although the indication for Nebido is for hypogonadism (Common effects of hypogonadism include decreased sexual desire, erectile dysfunction, muscle loss and weakness, depression, as well as an increased risk of osteoporosis), the name Nebido suggests that its primary function will be to elevate the libido in men. I do believe that the phosphodiesterases (e.g. Viagra, Levitra and Cialis) will still maintain their market preeminence and support by physicians since they have specificity for the primary problem associated with erectile dysfunction (ED) without the potential of increasing the risk associated with androgens.
If the parent company continues on its track of developing innovative compounds, it is likely that a large pharma or biotech company will either partner with them or enter into some equity agreement.
Ciao,
"The implant procedure consists of a small incision through which a trocar and cannula are inserted. The pellets are inserted through the cannula, and then the cannula is withdrawn. The incision is then closed with a Steri-Strip, and pressure is applied until bleeding stops, and the area is then covered with a dressing. We have not had any major problems in terms of side effects from this procedure. Some expertise is required in terms of placing the pellets so that underlying structures are not traumatized." Quote from the excellent website Human Health Solutions. (www.humanhealthsolutio...)
I feel that a medicine that involves a surgical procedure to take is not the same as one that can be given with an injection; that is why I did not include the scantly used Testopel in my article. Thank you all for your comments and allowing me to clarify my article.
Pellet - most invasive requires surgery. The FDA approved an operation as it is safer than an injection?
Gels - least invasive daily applications with fluctuation even when they remember to apply everyday. The FDA approved self medication over medical supervision?
What does Europe and the 70 countries worldwide who administer long-acting depot formulation understand that the FDA does not?
Low testosterone has huge medical, financial, social and emotional costs:
diabetes
coronary artery disease
hypothyroidism
hyperlipidemia.
increased body fat
poor concentration and memory
reduced bone and muscle mass
diminished libido
erectile dysfunction
decreased physical performance
The FDA wants to impose a 2 year delay because improper injection caused reversible shortness of breath and coughing?
Excellent to read the FDA’s integrity is being questioned not just by congressional hearings but by the public for which they suppose to serve and protect!
study. The safety issues are benign and well known therefore there
is no need for a new study.
1. gels aromatize to estrogen and will decrease bio-available testosterone after 6 months of use.
2. Testopel under Slate Pharma raised the price of the 75mg pellet from $12.50 to $60 each. Using 5 per month gets very expensive
3. The 3-month Nebido does not have a flat release, but will have a high initial blood level that triggers the same aromatization and then the low levels persist for months.
None work well. The best is weekly self-administered injections or compounded non-aromatizable testosterones. Cost $25-50 per week.
That is the 25 year truth.
I am well aware of the issues you sxpeak of here as far as the long-term ineffectiveness of Testosterone replacement therapy. I have suffered from hypogonadism since my early 20s, and I have felt the effectiveness of various forms of TRT diminish within a few months of use. I wonder if a powerful aromatase injhibitor such as Arimidex can be of value in restoring a more favorable testerone- estrogen ratio -- do you have any experience with Arimidex for this purpose? Also, how much can exercise (aerobic and/or weightlifting) help to trigger more production of testosterone? Are FH and LSH levels sensitive to activity such as exercise?
Thank you in advance for your response.
S
On Jan 29 09:39 PM usdoctor wrote:
> The truth is, since I am a physician who prescribes 'T' to hypogonadal
> men is that:
> 1. gels aromatize to estrogen and will decrease bio-available testosterone
> after 6 months of use.
> 2. Testopel under Slate Pharma raised the price of the 75mg pellet
> from $12.50 to $60 each. Using 5 per month gets very expensive<br/>3.
> The 3-month Nebido does not have a flat release, but will have a
> high initial blood level that triggers the same aromatization and
> then the low levels persist for months.
>
> None work well. The best is weekly self-administered injections or
> compounded non-aromatizable testosterones. Cost $25-50 per week.
>
>
> That is the 25 year truth.