Orexigen’s Contrave & FDA Approval – Is This The Weight Loss Supplement We’ve Been Waiting For?

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Anyone who keeps track of developments in the weight loss industry is probably eagerly watching the progress of Contrave, which could become the third weight loss drug to be approved by the FDA in the near future.

The fact that it is even being considered to be given the thumbs up by the FDA highlights exactly how highly it’s thought of, and just what it could do to overweight patients.

What Exactly is Contrave?

It would be fair to say that Contrave is made up of a slightly strange concoction. It’s based on two existing drugs; Wellbutrin and Naltrexone, with the former designed to treat depression while the latter is an addiction drug.

As you’ve probably gathered, the above two drugs means that Contrave doesn’t aim to physically reduce the amount of fat on a person, but it instead looks to control the patient from a mental perspective. Rather than working in the belly, it concentrates on the brain or more specifically, the hypothalamus.

This is actually the brain’s thermostat that is responsible for controlling our appetites, body temperature and even how we burn energy. As such, it’s already becoming clear just how Contrave can “change” the way our body’s deal with fat.

Over the years patients taking Wellbutrin for other issues have lost large amounts of weight. However, as soon as they come off the treatment they start to pile the pounds on. The addiction drug Naltrexone comes in to prevent this latter stage occurring, meaning that patients can now take true advantage of Wellbutrin without backtracking.

Is There Any Clinical Backing Behind The Drug?

Unsurprisingly, the manufacturers initiated a clinical trial several years ago that involved no fewer than 700 obese people. Testing was performed at the fifty six week stage and it was found that the average weight loss was 9.3% of their body weight, which equated to somewhere between 20 and 25 pounds.

Is Contrave Associated With Any Side Effects?

Unfortunately, the nature of this drug means that patients regularly experience side effects. Most of the time this revolves around mild nausea, although other reports have focussed upon headaches and constipation.

Perhaps one of the most pleasing parts about it was the lack of psychiatric symptoms though. Due to the make-up of this drug, there were some early suggestions that patients might be affected by depression. This has proved not to be the case and in a lot of instances, many actually felt happier than they did prior to taking the drug.

What is its History With The FDA?

Despite all of the optimism surrounding Contrave, it has been something of a rollercoaster ride for the manufacturers Orexigen. At first the omens suggested that FDA approval would be quite a straightforward process, but it gradually started to become clear that this would not be the case.

Following the decisions to approve Belviq and Qsymia in 2012, the general consensus was that Contrave would follow suit. However, the FDA have had concerns about the drug since 2011 and were demanding that the manufacturers sponsored a clinical trial to clarify the side effects. Primarily they were concerned about the increased risk of heart attacks, strokes or cardiovascular death.

Unsurprisingly, Orexigen followed such advice and enrolled no fewer than 9,000 obese patients to take part in a trial. As well as having weight management problems, many of these people were seen as being at risk for cardiovascular disease.

With so many patients taking part, it came as no surprise to see that a small portion, 87 to be precise, reported cardiovascular “events”. However, these were minor enough to satisfy the FDA’s initial targets, meaning that many are suggesting that the decision this month will be a foregone conclusion and Contrave will finally join the other two approved diet pills on the market.

A Summary on Contrave

The diet pill industry is likely to be holding its breath as Contrave awaits FDA approval. Unsurprisingly, at least given the immense clinical trial results, this is a pill that could change a lot of people’s lives. The general consensus is that it will fall somewhere in between the existing treatments that are available; with Qsymia currently regarded as the most powerful pill that is on the market.

Something that will work in Contrave’s favour is the fact that it isn’t classed as a “controlled substance”. This is a tag that has been placed on both Qsymia and Belviq, meaning that they are very difficult for patients to get hold of and doctors have a strict set of requirements before they are able to prescribe them.

The situation for Contrave should be much different though, with some suggesting that doctors will even be able to give out samples to their patients. Bearing such information in mind, it’s no surprise to see the amount of focus that has been placed on Contrave and how it could potentially permanently change the weight loss market.