Weight-loss category enters 2013 light on results

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Just in time for slimming New Year's resolutions, GlaxoSmithKline says it's unlikely that regulators will add obesity-fighting claims to GLP-1 diabetes drugs, reported Bloomberg. The report featured a quote from GSK's R&D chairman which dismisses that possibility due to the fact that the drugs aren't all that effective in helping to achieve weight loss.

Novo Nordisk has taken the opposite position, putting its diabetes medication Victoza through Phase III studies of the medication to test out its viability as an obesity treatment.

Novo's success could provide yet another tool for the 35.7% of US adults the CDC says are obese. It could also provide another alternative to gastric bypass surgery. Obesity means having a body mass index of at least 30. Overweight is a BMI of between 25 and 29.9.

The past year has also brought some new medical therapies into the mix, which have yet to garner sales that signify patient interest in lifelong drug treatments, or are still awaiting approval to dive into the consumer marketplace.

Vivus's Qsymia, which is being touted by 150 sales reps, has not been an immediate hit. The company is working on a modified REMS proposal that would allow it to distribute the drug using designated retail pharmacies. The company told MM&M in an earlier interview that the weight-loss trend is a seasonal one and that it expects things to take off during the first quarter. It launched a free 14-day trial promotion last month. In addition, Qsymia's failure to get the nod from European regulators could also be a contributing factor in its slow start.

Meanwhile, Arena snagged an FDA approval for its weight-loss drug Belviq (lorcaserin) back in June, but is still waiting for the Drug Enforcement Agency to classify the drug before it can begin marketing it. An Arena spokesman told MM&M by email that the company and Eisai, who will market the drug in the US, expect it will be tagged a Schedule IV drug. These drugs have a lower abuse risk when compared to Schedule III drugs, like Abbott's Vicodin (which is considered to have a lower abuse risk than Schedule II drugs like Oxycontin). Anxiety medications Xanax and Ativan are Schedule IV drugs.

Still hovering is Orexigen's Contrave, which had to undergo a heart safety study prior to FDA consider iation, slowing its pipeline progress compared to competitors. Company CEO Michael Narachi said in a September statement that the naltrexone SR/bupropion SR mix could get OK'd late next year and that the company is already working on marketing plans with co-promoter Takeda.  At the same time, it's hammering out the design of its clinical trials for another pipeline obesity drug, Empatic, which is a combination of bupropion SR and zonisamide SR.
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