Boston, MA 06/05/2014 (wallstreetpr) – Orexigen Therapeutics, Inc. (NASDAQ:OREX) announced that the United States Food and Drug Administration (FDA) planned to change the action date for the NB32 New Drug Application. The company announced that the USFDA informed it that the body would reassign the Prescription Drug User Fee Act (PDUFA) action date to June 11, 2014, the day prior to the original assignment. FDA, in its notice to Orexigen Therapeutics, said that it found out that the PDUFA date was miscalculated by it due to unintentional administrative error.
What is NB32?
NB32 is an investigational medication used for weight loss. It comes at a fixed dose combination along with Orexigen Therapeutics, Inc. (NASDAQ:OREX)’s proprietary SR version of naltrexone and bupropion sustained-release (SR) so as to improve the tolerability of the drug.
The medication is primarily used for cutting down the appetite by controlling cravings, improving better eating habits and increasing metabolism. Clinical trials have been conducted earlier on over 4500 people, and it has been found that NB32 can be used for weight loss effectively. In the study, it was found that 53% of the participants taking this medication and 21% taking placebo lost around 5% or more weight in 1 year trial period.
Obesity- a Serious Problem
The World Health Organization explains that obesity is the root cause of various ailments among thousands and millions of people across the world. If left uncontrolled, it can be also fatal. WHO explains that over 1.4 billion people aged 20 years and above were struggling with excess weight. Out of these more than 200 million males and around 300 million females were at the boundary line of obesity. More than 10% adult population of the world is obese. In the year 2012, it was found that over 40 million children below 5 years of age were either overweight or obese.
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