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Orexigen Therapeutics’ Contrave Awaits FDA’s Nod
- Updated: June 10, 2014
Obese people trying to lose weight could soon have yet another weight loss pill. The United States Food and Drug Administration is expected to make a decision by Wednesday this week and according to analysts FDA is likely to give the drug a go ahead. The drug is Contrave made by Orexigen Therapeutics.
In January 2011, FDA declined to approve Contrave. To request for FDA’s review and approval, Orexigen Therapeutics conducted a study spanning more than a year to gather evidence that the drug does not pose significant risk to a patient’s cardiovascular health. Through the study that involved over 8,000 patients, Orexigen gathered evidence suggesting that the drug is ‘safe or safe enough’.
In its research, it found that more than 50 percent of patients taking the drug achieved a 5 percent decrease in body weight. About 21 percent of participants taking placebo managed to achieve a five percent decrease in body weight. The team also noted that, unlike common diet pills such as Belvi by Arena and Qsymia by Vivu, Contrave has an ingredient capable of helping patients remain under the medication for longer which could make the drug more suitable for some patients. The ingredient is made up of a mixture of bupropion and naltrexone.
Piper Jaffray’s Duncan said they believe bupropion is behind greater drug persistence; it is an antidepressant and therefore helps patients feel better.
Each of the drugs meant for weight loss has its side effects. The three manufactures have been conducting researches aimed at finding out the risks that their drug use may pose to cardiovascular health. The studies also aim at finding out the effect of the drug on fetal health, mood among other health concerns.
Although there are concerns about its safety, analysts say that FDA is likely to give the drug a nod