Qnexa® Obesity Drug Information and News

Qnexa®

Qnexa® is produced by Vivus which is another medication, at the time of this writing in trials, being studied for the treatment of obesity. Qnexa is an appetite suppressant, it is a blend of two separate already existing medications Phentermine and Topiramate (brand name Topamax®). Phentermine has been approved by the FDA and has been used for many years as a very successful weight loss formula. Topiramate is a medication that has also been approved by the FDA and has been used for years as an anticonvulsant to treat epilepsy and has also been used to treat migraine headaches or as an antidepressant. However, it is the combination that is being tested and the results are promising.
It is believed that Qnexa will greater reduce appetite and increase weight loss than phentermine or Topiramate alone as well as show that it is a safer drug than either one substance by itself. Studies have shown that Qnexa has attained a larger weight loss compared to the placebo as well as compared to each of the two combined drugs individually. The FDA requires that in order for an obesity drug to be considered effective it must show that at least a third of the test patients lose at least 5% of their body weight. Qnexa passed this better than some.

Older News

May 10th 2006
Vivus, Inc. announced positive results from their clinical trial consisting of 200 people medically classified as obese, 159 woman and 41 men. The study took place at Duke University's Medical Center where it was double-blind, randomized and placebo-controlled. It was in these tests that more than half of the patients lost at least a 10% weight loss during the 24 week period. This equaled to approximately 25lbs where as the placebo group lost just less than 5lbs. The study also showed that there was no plateau effect towards the end of the study, rather the weight consistently was being lost by the patients. Of the patients enrolled in the study, only 4 patients taking the drug dropped out during its testing where as 19 actually dropped out who took the placebo.

June 13th 2006
The trademark patent for Qnexa is announced and it is good until and including into 2019.

November 9th 2007
Phase 3 testing of Qnexa was initiated. The clinical testing would consist of medically defined obese people whose body mass index (BMI) was at least 35 (People whose body mass index is over 30 are considered obese). It was to consist of approximately 1250 people in upto 120 different centers. The study was double blind, placebo, randomized for 56 weeks and consisted of at least 20% males.

For phase 3 testing Qnexa had the following doses used:

Full strength formula consisted of 15mg of Phentermine IR and 92mg of Topiramate CR.
Mid dose Qnexa consisted of 7.5mg Phentermine IR and 46mg Topiramate CR.
Low dose Qnexa consisted of 3.75mg Phentermine IR and 23mg Topiramate CR.

IR= Immediate Release Formula
CR= Controlled Release Formula

This testing was a once a day formula where as the first tests where a twice a day formula.

June 10th 2008
Midway phase 3 testing and Vivus released news stating that Qnexa lowered blood sugar as well as weight loss with patients having type 2 diabetes from tests involving 206 patients over a 28 week period. Qnexa achieved a 1.2% reduction in hemoglobin A1c compared to that of the placebo 0.6% reduction.

Dec 11th 2008
The first of the phase 3 testing results are made public. Vivus, Inc. states that its testing patients who where given the full dose of Qnexa had lost an average of 9.2% of their body weight. This first part group consisted of 756 people over 28 weeks. The mid dose group lost an average of 8.5% and the placebo controlled group only 1.7%.

Jan 13th 2009
It is announced that the European Patent office has issued Vivus, Inc. a patent for Qnexa.

More Recent News

On Sept 9th 2009 During the trial 3 phases of tests over a 56 week period, Qnexa showed an average weight loss of 14.7% along with a benefit in cardiovascular factors. It also showed encouraging tolerability and a positive benefit to risk factor.
Although Qnexa showed favorable test results with regards to weight loss, tolerability and risk, there are risks and potential side effects. Some of these are the feeling of 'pins and needles' on the skin, dry mouth, taste changes, constipation and others.

December 29 - 2009
Vivus, Inc. has submitted Qnexa to the FDA today. Expect sometime in 2010 (Probably mid to late 2010) to find out if the FDA passes it.

Jan 07 - 2010
Vivus, Inc. released news today stating that Qnexa had a positive result in reducing sleep apnea (a condition where people have moments of difficulty breathing or momentarily stop while sleeping). It was a smaller study with 45 overweight men and women between ages 30-65 that lasted 28 weeks. Vivus, Inc. stated that there was a 69% decrease in sleep apnea.

Jan 22nd - 2010
Although not directly related to Qnexa or any of the other potential future diet medications, I thought it should be pointed out that currently approved Meridia (generic sibutramine) prescribed for obesity for more than a decade has been given a heart attack warning. For people with existing heart conditions, Meridia can increase the risk of stroke or heart attack when compared to a placebo in studies. As a result, the European Medicines Agency has banned sibutramine which in Europe is usually known by its trademark names of Reductil or Ectiva. The FDA has not banned it in the US but has insisted that Abbott Laboratories, the maker of Meridia put stronger warnings on it.

Jan 26th - 2010

Today there was a drug approved by the FDA for diabetes called Victoza, however it is the comment shown that relates to Qnexa
"The Victoza approval could also bode well for Vivus Inc.'s potential obesity drug Qnexa, said Merriman Curhan Ford analyst Michael G. King Jr. in a note to investors. "The ability to put the risk-benefit ratio into the proper perspective suggests to us that there is no blanket regulatory bias for or against drugs for diabetes and obesity," he said.

March 1st - 2010

Vivus Inc annouced today that the FDA has accepted the filing for Qnexa. The target date for the FDA to complete its review is October 28th 2010.

March 8th - 2010

3 additional patents where filed today for Qnexa mainly for methods of using Qnexa in different beneficial applications. These include composition-of-matter protection, additional protection in weight loss uses as well as dosages, controlled release formulations, and methods of use including sleep apnea. "The three new patents significantly expand on the intellectual property coverage afforded Qnexa, and the issuance of these patents indicates that the USPTO clearly continues to recognize the unique aspects of Qnexa," stated Peter Tam, president of VIVUS. "Together with the original Qnexa patent, these new patents provide substantial protection for our Qnexa franchise into at least 2020."

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