Men now have yet another option for testosterone replacement therapy. Is this one truly different and if so, how?
The newest testosterone replacement product — recently approved by the FDA — is an intramuscular injection that will be marketed under the brand name of Aveed (Testosterone undecanoate) by Endo Pharmacueticals. Aveed has received the FDA's approval for treating male hypogonadism, or low testosterone. This was announced by the FDA and the drug maker late last week. Aveed joins the long list of approved medical options for treating men with a diagnosis of low testosterone or hypogonadism.
The long-acting testosterone product was cleared by the FDA for an initial treatment dose at 3 ml (750mg), another dose at 4 weeks, and then every 10 weeks afterward. This will represent a truly unique dosing option in contrast with many men that now require injections every one to two weeks. The currently available testosterone for injection is also intramuscular, but does not have the long lasting effect that the newer formulation can offer.
All the details have not been released by the FDA or Endo Pharmaceuticals, but it appears that patients must remain in the administering physician's office or clinic for at least 30 minutes after the injection so that short-term reactions may be observed and treated.
In January, the FDA announced a large scale review into the risks associated with testosterone products. This recent announcement however was accompanied by specific comments by the FDA about this ongoing investigation. FDA spokeswoman Andrea Fischer said in a statement that the FDA is continuing its review of testosterone products, but there is no evidence that Aveed's risks are any greater than those of other testosterone drugs already on the market.
"The FDA's current view is that the benefits of testosterone therapy, including Aveed, outweigh the known risks when used as directed in patients for whom the drug is indicated," Fischer said.
More information will likely be released in the coming weeks regarding the particular details about Aveed and how patients interested in this option should proceed. It appears this new ‘long acting’ testosterone injection will be given only in physician offices as the patient must remain on site for monitoring for about 30 minutes.
Posted on Mon, March 10, 2014
by Shane Geib, M.D. filed under