On Monday we reported on three new weight loss drugs that were scheduled to come before FDA committees in the next few months. The first faced the firing squad this week and lost their bid. While it is only the opening salvo and doesn’t guarantee FDA rejection, it is a blow.
An FDA advisory committee voted 9-7 to reject Vivus’s application to approve Qnexa, citing concerns over side effects. Typically non-approval by the committee means that the Food and Drug Administration will not approve the drug, although they are only recommendations and the FDA has been known to overrule committee votes.
Qnexa is a mixture of two existing drugs, an anticonvulsant (topiramate) and an amphetamine (phentermine). Topiramate has the effect of leaving the user fuller and more satisfied, while the phentermine curbs appetite. There are side effects, as with almost any medication. In the case of Qnexa, memory and concentration problems were the main complaints. Many thought that the success of the drug might weigh heavily in favor of approval, given that test subjects lost 13 to 15 percent of their body weight in the trials.
While it might be back to the drawing board for Qnexa, there are still two more weight loss drugs coming up for review. Contrave by Orexigen Therapeutics Inc. is scheduled for the committee in October, while lorcaserin from Arena Pharmaceuticals Inc is set for December.
Contrave has a similar formulation to Qnexa, utilizing both an anticonvulsant and an amphetamine but in different dosages. Lorcaserin is completely different, and with less side effects than the anticonvulsant/amphetamine mixture.
If you are looking for a weight loss plan that does not include prescription medication, visit the HealthNews diet pages and test out our Individual Diet Selection tool, which can help find the right diet for you lifestyle.
For more
An FDA advisory committee voted 9-7 to reject Vivus’s application to approve Qnexa, citing concerns over side effects. Typically non-approval by the committee means that the Food and Drug Administration will not approve the drug, although they are only recommendations and the FDA has been known to overrule committee votes.
Qnexa is a mixture of two existing drugs, an anticonvulsant (topiramate) and an amphetamine (phentermine). Topiramate has the effect of leaving the user fuller and more satisfied, while the phentermine curbs appetite. There are side effects, as with almost any medication. In the case of Qnexa, memory and concentration problems were the main complaints. Many thought that the success of the drug might weigh heavily in favor of approval, given that test subjects lost 13 to 15 percent of their body weight in the trials.
While it might be back to the drawing board for Qnexa, there are still two more weight loss drugs coming up for review. Contrave by Orexigen Therapeutics Inc. is scheduled for the committee in October, while lorcaserin from Arena Pharmaceuticals Inc is set for December.
Contrave has a similar formulation to Qnexa, utilizing both an anticonvulsant and an amphetamine but in different dosages. Lorcaserin is completely different, and with less side effects than the anticonvulsant/amphetamine mixture.
If you are looking for a weight loss plan that does not include prescription medication, visit the HealthNews diet pages and test out our Individual Diet Selection tool, which can help find the right diet for you lifestyle.
For more
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