Contrave Waiting On The FDA For Approval; Orexigen's Diet Pill Waiting For Drug Classification
A new weight-loss drug might be released out onto the market soon, giving consumers a third pill to try and treat obesity. Orexigen Therapeutics Inc. announced that the Food and Drug Administration (FDA) is re-evaluating and possibly approving Contrave, a weight-loss medication, after it conducted another study to test its efficacy, and more importantly, its safety.
Originally Contrave, also called NB32, was turned down by the FDA in January 2011 because of its questionable cardiovascular safety and lack of long-term side effects. However, Orexigen applied for regulatory approval in December 2013, when their November study revealed more promising results.
The Contrave Light Study was a double-blind, placebo-controlled trial with 8,900 patients in order to evaluate exactly how the heart could handle the drug. The tests resulted in a 95 percent confidence that there would be no risk of major adverse cardiovascular events (MACE) in patients who received Contrave compared to the placebo. The Contrave clinical trial patients lost an average of five percent of their body weight over the 12-month trial duration.
There are currently two competitors on the market that were FDA-approved: Qsymia and Belviq. In 2012, Qsymia became the first weight-loss pill approved for pharmaceutical sale in 13 years. Belviq was approved in 2009 but didn’t reach the market until 2013 as a prescription weight-loss medication that, when combined with diet and exercise, showed improved results. In trials of those taking Qsymia, patients lost an average of nine percent of their body weight, while those taking Belviq lost an average of just three percent.
Orexigen is a biopharmaceutical company that focuses on the treatment of obesity, which is a lucrative business to get into considering more than one-third of adults in the United States are obese, according to the Centers for Disease Control and Prevention. Obesity carries with it many related conditions, which include heart disease, stroke, type 2 diabetes, certain types of cancer, and sleep apnea.
According to the company’s website, “Orexigen’s product candidates, NB32 and Empatic reflect the Company’s understanding of how the brain appears to regulate appetite and metabolism, as well as the mechanisms that come into play to limit weight loss over time.”
Orexigen explains NB32 is “believed” to reduce appetite, help control cravings, increase metabolism, and improve control in overeating behaviors. Previous clinical trials included more than 4,500 participants who lost an average of 25 lbs. in a six-month period, compared to those taking the placebo and using a weight management program, who lost 17 lbs. It works by increasing levels in the dopamine reward system of the brain, which increases energy expenditure and ultimately helps complement weight-loss regimens of diet and exercise.
Empatic is Orexigen’s second medication for weight loss and is in earlier stages of FDA-approval. The drug also affects the brain’s dopamine levels in addition to suppression and stimulation of different neurons. Over the course of 24 weeks, patients lost 9.9 percent of their body weight, which was on average 22 lbs. compared to the 1.7 percent of weight from the placebo group.
The FDA is expected to make its decision by Wednesday, and many analysts expect approval. Wells Fargo analyst Matthew Andrews told CNBC News that he estimates Contrave will accumulate $1.2 billion in revenue by 2020.