Endo clears the FDA with thrice-spurned drug as 'low-T' controversy boils

In its fourth trip to the FDA, Endo's ($ENDP) testosterone-boosting Aveed finally won over regulators, but as the clamor over risks tied to "low-T" treatments reaches deafening volume, the in-transition drugmaker may be late to a profitable party.

Aveed is an intramuscular injection designed to treat adult men with testosterone deficiency, or hypoganadism, administered every 10 weeks after an initial dose. The FDA first rebuffed Aveed in 2009 over safety concerns and then twice more because Endo's risk-mitigation plans left regulators wanting. Now, with the company promising to educate prescribers and restrict distribution, the agency has finally smiled on Aveed, giving Endo an entry into a multibillion-dollar market when it launches the drug this month.

But delays are costly, and doubly so amid a sea change. More and more studies have come to light tying testosterone treatments to increased risks of stroke, heart attack or death, and activists are calling on FDA slap black-box warnings on top-selling low-T treatments from Eli Lilly ($LLY), AbbVie ($ABBV) and others. IMS Health has said the market for testosterone treatments will hit $5 billion by 2017, but with lawsuits and regulatory scrutiny gaining steam, the rapid growth of the low-T market may be a thing of the past.

And Endo's years-late debut in the field typifies the pharma outfit's recent fortunes. With generic competition looming for its workhorse products, the company is shedding jobs and business units in an effort to pare down and focus on specialty drugs. Earlier this year, the Malvern, PA, drugmaker made a bid to acquire pain-patch outfit NuPathe but lost out to Teva ($TEVA), which swooped in with a better offer at the last minute. Now the company is expecting revenue to shrink once more in 2014.

Endo's low-T treatment proved itself capable of restoring testosterone to healthy levels in an 84-week Phase III trial, the company said, but the injection will ship with a boxed warning for serious pulmonary oil microembolism reactions and anaphylaxis. Endo picked up the drug in its $370 million buyout of Indevus Pharmaceuticals back in 2009.

- read the announcement

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