Antoaneta Sawyer, PhD
Vivus Inc. a biopharmaceutical company- producer of the new generation weight loss drug- Qnexa®, with encouraging weight loss results offering a great promise for a sensible weight loss in both, overweight and obese patients, is seeking for final FDA approval. (Source, Vivus)
Qnexa® is a drug combination of two drugs- Phentermine and Topiramate that are believed to work synergistically addressing satiety and appetite in patients who are overweight or obese. The expected effect of the drug is directed to address the metabolic syndrome cluster effects: hypertension, type 2 diabetes, dyslipidemia, central adiposity, including sexual health. (Source, Vivus)
Phentermine, known as the most widely prescribed weight loss pill in the U.S., was approved in 1959 for a short period of treatment in obesity. Caloric restriction, behavior modification and daily exercise are prescribed as an adjunct to the drug that must be used for a period of several weeks. Topiramate is an anticonvulsant drug FDA approved (1996) as antiepileptic drug and later on as a prophylactic drug for migraine. (Source, WebMD, Wiki, Answers)
Vivus Inc. a biopharmaceutical company- producer of the new generation weight loss drug- Qnexa®, with encouraging weight loss results offering a great promise for a sensible weight loss in both, overweight and obese patients, is seeking for final FDA approval. (Source, Vivus)
Qnexa® is a drug combination of two drugs- Phentermine and Topiramate that are believed to work synergistically addressing satiety and appetite in patients who are overweight or obese. The expected effect of the drug is directed to address the metabolic syndrome cluster effects: hypertension, type 2 diabetes, dyslipidemia, central adiposity, including sexual health. (Source, Vivus)
Phentermine, known as the most widely prescribed weight loss pill in the U.S., was approved in 1959 for a short period of treatment in obesity. Caloric restriction, behavior modification and daily exercise are prescribed as an adjunct to the drug that must be used for a period of several weeks. Topiramate is an anticonvulsant drug FDA approved (1996) as antiepileptic drug and later on as a prophylactic drug for migraine. (Source, WebMD, Wiki, Answers)
Qnexa® is in its 3d clinical phase of approval, seeking final registration by the U.S. FDA, being evaluated in over 4,500 patients as a treatment for obesity, completed under a special protocol assessment (SPA) by the FDA. Despite its final stage Qnexa® is currently not approved. There were three separate studies performed at its first clinical phase. The first study (EQUATE) evaluated the drug in 756 obese patients over 28 weeks at 32 sites. The second (EQUIP) and the third (CONQUER) studied the drug for 56-weeks in 1,267 morbidly obese people (with or without co-morbid conditions) and 2,487 overweight and obese patients, (with at least two co-morbidities) respectively.
There were found the following encouraging results:
A. Weight loss of up to 14.7% (37 lbs) was achieved by patients treated with the drug across the 56 weeks in the EQUIP study.
B. During the two 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.
C. There were found statistically significant results of improvement in all (cardiovascular, metabolic and inflammatory) metabolic risk factors among patients treated with the drug
D. The efficacy points of reference (benchmarks) for weight loss agents were exceeded at all three doses of the drug
E. The therapeutic results were significantly (69%) higher than the placebo results at all three doses of Qnexa®, showing good drug tolerability (Source, Vivus)
Tomorrow (July, 15) an FDA advisory committee meeting will be taking place to evaluate Qnexa® for obesity treatment. It is expected that upon the conclusion of the meeting, a panel of medical doctors is preparing to make a recommendation on the drug's approval. The FDA has set October 28, 2010 as the date by which the agency will make a formal decision on the approval of the drug.
FDA decided to publish the background material at the location of the advisory committee meeting (prior to the meeting), and the material is expected to be published on the FDA's web site (after the meeting). The Committee is supposed to discuss the safety and efficacy of new drug application (NDA, 22-580), with the trade name Qnexa® (Phentermine/Topiramate). FDA briefed in their online publications (this Thursday) that the review panel should take into account a number of potential side effects, despite acknowledging the drug’s effectiveness in helping patients losing weight. It is expected that FDA will announce its final decision in October, 28 (2010). (Source, FDA) Given two-thirds of adults in the United States are either overweight or obese, weight loss products, such as Qnexa®, may have widespread exposure, and the potential for associated safety issues must be considered," the FDA said, as the Associate Press reported. (Source, HealthNews)
There were found the following encouraging results:
A. Weight loss of up to 14.7% (37 lbs) was achieved by patients treated with the drug across the 56 weeks in the EQUIP study.
B. During the two 56-week studies, the most commonly reported side effects were dry mouth, tingling and constipation.
C. There were found statistically significant results of improvement in all (cardiovascular, metabolic and inflammatory) metabolic risk factors among patients treated with the drug
D. The efficacy points of reference (benchmarks) for weight loss agents were exceeded at all three doses of the drug
E. The therapeutic results were significantly (69%) higher than the placebo results at all three doses of Qnexa®, showing good drug tolerability (Source, Vivus)
Tomorrow (July, 15) an FDA advisory committee meeting will be taking place to evaluate Qnexa® for obesity treatment. It is expected that upon the conclusion of the meeting, a panel of medical doctors is preparing to make a recommendation on the drug's approval. The FDA has set October 28, 2010 as the date by which the agency will make a formal decision on the approval of the drug.
FDA decided to publish the background material at the location of the advisory committee meeting (prior to the meeting), and the material is expected to be published on the FDA's web site (after the meeting). The Committee is supposed to discuss the safety and efficacy of new drug application (NDA, 22-580), with the trade name Qnexa® (Phentermine/Topiramate). FDA briefed in their online publications (this Thursday) that the review panel should take into account a number of potential side effects, despite acknowledging the drug’s effectiveness in helping patients losing weight. It is expected that FDA will announce its final decision in October, 28 (2010). (Source, FDA) Given two-thirds of adults in the United States are either overweight or obese, weight loss products, such as Qnexa®, may have widespread exposure, and the potential for associated safety issues must be considered," the FDA said, as the Associate Press reported. (Source, HealthNews)
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