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Contrave: Is This The Weight Loss Drug We have Been Waiting For?

Jun 10 2014, 8:30am CDT | by

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Contrave: Is This The Weight Loss Drug We have Been Waiting For?

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Contrave: Is This The Weight Loss Drug We have Been Waiting For?

Will the FDA finally approve Contrave, Orexigen’s hot new diet drug, this week? Expectations are high for this new weight loss medication, which could prove an important anti-obesity aid. The ruling is expected as soon as tomorrow.

Now temporarily renamed NB32, Contrave was eagerly awaited when it got a startling thumbs-down from the FDA in 2011. The agency demanded additional research into cardiovascular risks.

Orexigen resubmitted its application for Contrave in December 2013, citing “encouraging” positive interim results from the 8900-patient Light Study, still ongoing. As summarized by the Independent Data Monitoring Committee, the interim Clinical Study Report (CSR) appears to proveContrave/NB32 safe, or safe enough.

With the FDA’s doubts thus addressed, expert consensus has the agency voting yes on NB32. Then again, if the history of weight loss drugs tells us nothing else, it’s that no weight loss drug’s success is a sure thing.

But let’s stick with what we do know right now. If you’re overweight and hoping Contrave/NB32 can help you, here’s what you need to know about this new weight loss drug treatment.

1) Contrave (NB32) is likely to be less effective than Qsymia, more effective than Belviq. That’s a major generalization, but in trials those taking Qsymia lost an average of 9 percent of their body weight, while those taking Belviq lost an average of just 3 percent. Clinical trials show those taking NB32 lost an average of 5 percent of their body weight.

2) Contrave (NB32) may be easier to obtain. Both Qsymia and Belviq are considered controlled substances, placing stiff limits on how doctors prescribe them. NB32 is not expected to be approved as a controlled substance, meaning doctors can hand out samples and meet less stringent criteria when prescribing.

3) Obesity treatment – and insurance coverage – is easier to get now. According to recent data from the Centers for Disease Control, 35 percent, or more than one in three American adults, are obese. Yikes. With that in mind, the powers that be (aka the American Medical Association) finally in June 2013 classified obesity as a disease. This should – at least in theory – make it easier to get weight loss drugs and other treatments prescribed and covered by insurance. The Affordable Care Act (Obamacare) also mandates obesity prevention and treatment, which should help in the cost/coverage department too.

 4) Some people need the extra help of a drug.  According to a growing body of research, eating a high-fat diet and being overweight may, over time, cause metabolic changes that can make it difficult or impossible to lose weight on your own. Damage to the brain’s signaling system can affect the cues that tell you when you’re hungry and when you’re full, leading you to overeat. In this case, weight loss drugs may help you push the “reset” button on your metabolism.

5) Obesity drugs have side effects. The reason it’s taken three years for the FDA to approve NB32/Contrave is that obesity drugs have serious side effects. So serious, in fact, that several major diet drugs have been yanked from the market, making doctors, regulators (and yes, investors) shy away. Cardiovascular disease and mood problems are just two of the potentially serious side effects associated with Qsymia and Belviq. Older drugs Xenical  and Alli carry a risk of permanent liver and kidney damage. And those weight loss supplements you buy over the counter? Some are deadly.

6) Contrave might lighten your mood as well. Like Qsymia, NB32 is a combination of two separate drugs, naltrexone, best known as a treatment for alcoholism, and bupropion, the antidepressant in popular Wellbutrin. Thanks to the buproprion, trial participants reported that Contrave made them feel better, as well as look better.

Contrave Not the Last Word in Weight Loss Drugs

Despite the rocky route that’s faced recent weight loss drug approvals, more drugs are in development, including a second drug from Orexigen. Known as Empatic, it’s also a two-drug combo, this time combining bupropion with the anti-seizure drug zonisamide.

Empatic recently completed a Phase 2B clinical trial with Phase 3 trials in the planning stages. While that puts Empatic at least two years out, word is the FDA won’t require Empatic to undergo cardiovascular safety trial (speeding up the approval process) if  Phase 3 trial results are similar to those for NB32. Stay tuned.

For more health news, follow me here on Forbes.com, on Instagram and Twitter @MelanieHaiken, and subscribe to my posts on Facebook.

 

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