FDA Rejects Weight Loss Drug Qnexa
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New reports say the Food and Drug Administration has rejected Vivus Inc's petition for an approval to market a prescription weight loss drug called Qnexa in the United States.
The FDA requested additional data on the risk of birth defects and increased heart rate associated with use of the anti-obesity medication.
Qnexa is said to be made of two existing drugs phentermine and topiramate. Early in July, an FDA advisory committee voted to recommend the agency not to approve the drug citing safety concerns.
Phentermine, an anorexigenic agent is indicated as a short-term ( a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral mdofication and caloric restriction in the management of exogenous obesity for patients with an initial body mas index of 30 kh/m2 or higher or an BMI of 27 or higher, but having other risk factors such as hypertension, diabetes, and hyperlipidemia, the FDA says in a document.
The known possible adverse effects associated with phentermine include primary pulmonary hypertension and valvular heart disease, according to drugs.com
The other drug included in the antiobesity drug Qnexa topiramate is indicated as a monotherapy or adjunctive therapy for Epilepsy.
This medication may apparently result in more side effects including acute myopia and secondary angle closure glaucoma, oligohidrosis and hyperthermia, suicidal behavior and ideation, cognitive/neuropsychiatric adverse events, withdrawal of AEDs, and sudden unexplained death in epilepsy.
Other possible side effects include hyperammonemia encephalopathy kidney stones, paresthesia, renal failure, and decreased hepatic function.
Vivus Inc said it can address FDA concerns about the safety issue with data readily available.
Leland Wilson, chief executive of Vivus, which is based in Mountain View, Calif was quoted as saying "We have a plan to answer the FDA's questions."
The fact the agency did not request more clinical trials promotes investors to speculate that Qnexa may get approved soon.
Vivus was cited as by ALtimes as saying a 2-year study of more than 4000 patients showed that Qnexa led to an average weight loss of more than 10 percent of the total body weight, and it was not associated with increased cardiovascular risk in patients on the drug, compared with controls.
David Liu
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