New results from low-T trial point to early win for AbbVie's AndroGel

Early results are in from a study of low-T treatments in older men, and AbbVie ($ABBV) has a reason to celebrate. The trial showed that men who used the company's AndroGel for low testosterone had improved libido, even though the product did not significantly boost their energy levels or walking ability.

Findings from the first 3 of 7 studies published this week in the New England Journal of Medicine (NEJM) showed that AndroGel improved sexual activity, desire and erectile function compared with a placebo in men with low sexual function. But low-T treatments did not help the men walk farther or improve their vitality or energy levels. Some men did report feeling less depressed and in a better mood after getting the treatment, though, The Wall Street Journal reports.

The $50 million, multicenter Testosterone Trial is mostly funded by the federal government and included a total of 790 men ages 65 and older with testosterone levels below the average for younger men aged 19 to 40. Half of the subjects used AbbVie's AndroGel, and another half used a placebo for one year. The study did not include men with significant health issues such as heart disease or prostate cancer risk, according to the WSJ story.

Even though low-T makers are cheering, doctors are divided about the results. It's still "premature to recommend testosterone treatment of older men who have low-T for no discernible reason other than age," University of Pennsylvania endocrinologist and the principal investigator on the study Peter Snyder told the newspaper.

And there isn't any data showing long-term risks associated with the treatment, some critics of the study say. The results could encourage large numbers of men to take the drug without knowing answers about safety, Dr. Joel Finkelstein, a professor at Harvard, told The New York Times. "Testosterone is clearly not a panacea," Finkelstein said.

Doctors started raising concerns about the products a few years ago, after testosterone drug sales took off thanks to expensive ad campaigns from companies such as AbbVie and Eli Lilly ($LLY). Prescriptions for the low-T treatments shot up to 2.3 million between 2009 and 2013.

But many of those prescriptions were written without men getting testosterone testing first. And some patients turned to the drugs for lifestyle reasons, rather than medical reasons, prompting the FDA to issue new rules about prescribing.

The agency last year ordered testosterone therapy manufacturers to warn doctors that the products aren't approved for treating age-related low-T. Regulators also called for warnings about heart attack and stroke risks in men who use the drugs.

At least one company making low-T products is heeding the call for more safety data. Last summer the FDA asked testosterone gel makers to work together to launch a trial to examine heart risks associated with the drugs. Now AbbVie is working with the FDA and other manufacturers to develop a post-marketing clinical trial to study safety issues, AbbVie spokesman Morry Smulevitz told the NYT.

- read the WSJ story (sub. req.)
- here's the NYT article (sub. req.)

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