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FDA denies approval to long acting testosterone injections

Posted Dec 03 2009 12:00am
Endo's drug is Nebido, a long acting injectable (testosterone undecanoate) , that has been available in Europe, Mexico, and many countries for years. It requires injections every three to four mouths instead of every week or two. Too bad the FDA made this decision.

This shows how difficult it is getting drugs approved now at the FDA with review panels that do not know much about the science (review panel members cannot have any conflict of interests and be part of any data review panels for any companies,which excludes a lot of the experts in the field). Anaphylactic reactions are common side effects with all approved testosterone injectables due to bad injection technique, so it is amazing that they stopped this approval based on a side effect that is well known with currently available testosterone products in the United States. Common symptoms of anaphylactic reactions with testosterone injections are cough and dizziness that subside after a few minutes. It is believed that this happens when testosterone enters the blood stream and ends up in the lungs (injections are meant to form a "pocket" for slow release in the muscle. Some people may inject in a blood vessel and have anaphylactic reactions). I have had this reaction and found a quick solution to it: breathe into a paper bag until the cough stops.

Nelson


http://www.reuters.com/article/americasMergersNews/idUSN038783120091203

NEW YORK, Dec 3 (Reuters) - U.S. health regulators declined to approve Endo Pharmaceuticals Holdings Inc's (ENDP.O) drug for low testosterone, requesting more information about rare but serious side effects, the specialty drugmaker said on Thursday, sending its shares down nearly 4 percent.

The U.S. Food and Drug Administration wants information about anaphylactic reactions following injection of the drug, and about events when a poor injection technique leads to oil leaking into the lung, causing coughing.

In its so-called complete response letter, the agency also said Endo's proposed strategy to mitigate risks for the drug, Aveed, was not sufficient.

Endo said it was evaluating the FDA letter. The drug is sold outside the United States by Germany's Bayer AG (BAYGn.DE) and is available in more than 50 countries under the brand name Nebido. Endo licenses Aveed from Bayer.

Jefferies & Co analyst Corey Davis said Endo may choose to end its development of the drug if it cannot resolve the FDA's concerns.

"It's hard for us to imagine what the company could do to satisfy FDA concerns over exceedingly rare events that we would guess are not even product-specific in the first place," Davis said in a research note.

However, Davis said consensus estimates for Aveed sales had been "relatively modest" at $94 million by 2012.

An Endo spokesman said it was not yet clear what the next steps for the product would be. "Our goal is to work closely with the agency," the spokesman, Kevin Wiggins, said.

Aveed was one of the main products Endo acquired earlier this year in its $370 million purchase of Indevus Pharmaceuticals, a deal designed to expand its product line beyond pain treatments.

"It clearly casts a cloud on their ability to make acquisitions," said Jim Molloy, an analyst with Caris & Co. "They made it very clear they are looking to acquire more things. This one didn't go so well, so there's going to be some scrutiny on what the next one will be."

Low testosterone, also known as hypogonadism, is linked to symptoms such as fatigue, loss of muscle mass and decreased libido, and there is increasing evidence of an association with conditions such as diabetes and cardiovascular disease, according to Endo.

The Aveed action marks the second regulatory setback for Endo in as many months related to a testosterone product. In October the FDA delayed approval of Endo's Fortesta, a gel for men with low testosterone.

In September the FDA extended its review of Aveed by three months.

Endo shares fell 86 cents, or 3.8 percent, to $21.56 in afternoon trading on Nasdaq.

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