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19
Jun

Are you having problems with your being overweight? Do you want to take a weight loss drug  that can aid you with your weight reduction goals? Are you waiting for the release of the next successful and safe weight loss drug in the market? Yes? Well, sad to say, there is one bad news waiting for you.

The maker of the new diet drug Contrave has released its statement that it will most likely shelf its application with the Food and Drug Administration until there is a clear possibility that the said drug will be approved.

The hopes were high for Contrave’s approval in December 2010 when the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee members gave a thumbs-up with an overwhelming 13 to 7 vote. However, the Food and Drug Administration itself disagreed, saying that it needs the manufacturer to submit a study that has a satisfactory population size and duration to determine the possible increased blood pressure and heart problems associated with the intake of the said weight loss drug. The FDA’s decision resulted in a mixed reaction among obesity experts, some saying that FDA is giving an unfair advantage for other weight loss agents while others see FDA’s decision as the good choice.

In a press release just broadcasted last week, the drug maker agreed to meet with the Food, Drug Administration to have a better clarity about the latter is stand regarding the issue, and left the meeting feeling disappointed. The company proposed its plan of marketing Contrave in a narrow group of patients with a very low cardiovascular risk. However, FDA hardheartedly disagreed. The FDA’s Division of Metabolic and Endocrinologic Products requested the company to submit a larger study before it can be granted approval for market release.

As a result, Orexigen, the maker of Contrave plans to find marketing opportunities in other countries and for the time being drop its plans of gaining the FDA’s prized approval.

Contrave, which is produced by the Orexigen Therapeutics, is an extended-release formulation of the combination of naltrexone and bupropion. A study released by Orexigen shows that it is an effective drug for losing weight. However, until such time when the FDA gives its green light to this new weight loss drug, there is really no way we can possibly prove and know.

Reference:

Orexigen: Press Release: Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA

Category : News

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