Vivus, the California based biopharmaceutical company today announced the results of a two-year study of Qnexa. Qnexa (which has been covered by us many times) comprises phentermine and topiramate and is hoped to be approved as a weight loss medication. Qnexa got the thumbs down by an influential committee of the Food and Drugs Administration in the US a few months ago based on the fact that they only presented data for 1 year.
The results announced today were taken from the SEQUEL study, which was a 52-week study for a specific group of patients who had participated in the CONQUER study prior to this. Altogether, the results comprise 108 weeks of research so this may satisfy the FDA. In the SEQUEL study, patients were given the same treatment that they were given in the CONQUER trial including a top-dose, a mid-dose or a placebo and were asked to reduce their intake of food by 500 calories per day.
Patients taking the high dose of Qnexa were successful in losing weight and were able to maintain the weight loss. An average of 11.4% of their original body weight was reported to have been lost and the loss maintained. No serious side effects or complications were reported other than constipation, tingling in the fingers and toes, dry mouth, altered taste and problems sleeping.
The reports were not just glowing regarding weight loss but the drug contributed to improvements in related ailments and conditions such as high blood pressure and high levels of cholesterol and fats in the blood and diabetes. For those patients without diabetes, the numbers developing the disease dropped significantly, reducing the incidences by 54% at the mid dose and 76% at the top dose.
The SEQUEL study showed that those taking the top-dose of Qnexa experienced a weight loss and maintained this loss for 2 years with a reduction of 11.4% of their original body weight observed. Those taking the mid-dose lost and maintained a loss of 10.4%. Comparing this to the placebo where only a 2.5% weight loss was experienced, the reports are promising.
The majority of patients taking Qnexa lost more than 10% of their original body weight, which is a benchmark that is looked at in terms of additional health benefits derived by formerly obese people. In addition, there was no evidence or report of suicidal attempts, depression rates improved and there was a substantial decrease in the instances of anxiety, cardiac disorders, and sleep disorders in the SEQUEL study compared with the CONQUER study of one year.
Out of 4,323 patients included in the reports of the SEQUEL study, the rates of serious cardiovascular and neurovascular events were similar to the placebo, with a risk of 0.59%.