Qnexa® Obesity Drug Information and News

Qnexa®

Qnexa®, produced by Vivus Inc, is a medication being studied for the treatment of obesity. Qnexa is an appetite suppressant and 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 most.

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.

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."

March 26th - 2010

It has been announced today that an FDA advisory committee, The Endocrinologic and Metabolic Drugs Advisory, is tentatively scheduled to review Qnexa on July 15 2010. After this report, there should be a clearer indication of Qnexa's chances of being approved.

April 27th - 2010

A Brean Murray Carret analyst Jonathan Aschoff, gave Vivus (maker of Qnexa) a buy rating on their stock and is predicting an acceptance from the FDA on the trial drug in October. He also anticipates that Vivus will partner up with a larger pharmaceutical company once (if) it is approved to help market it.

April 28th - 2010

Data on Qnexa will be featured at the American Society of Hypertension's Annual Meeting in New York, NY. Vivus will make the presentation "Once-Daily, Low-Dose, Controlled-Release Phentermine/Topiramate (PHEN/TPM CR) Improves Blood Pressure and Results in Weight Loss in Overweight/Obese Patients Through 28 Weeks."

The meeting and exposition takes place May 1st through May 4th. At the meeting Oparil, a consultant for Vivus stated:

"Today, 68 percent of men and women in the United States are overweight or obese, this is a growing epidemic and has severe implications because obesity is associated with comorbidities such as cardiovascular disease, diabetes and hypertension."

"Patients taking this drug were able to lose clinically significant weight, saw clinically significant improvements in blood pressure and were able to sustain these health gains for a year. As such, we believe our study shows that this is a novel treatment that can lead to significant weight reduction in obese/overweight adults and may alleviate common obesity-related comorbidities such as hypertension."

May 7th - 2010

Further specifics from the American Society of Hypertension's Annual Meeting shows that systolic blood pressure dropped 5 to 7 mm Hg after a 28 week treatment of Qnexa with three randomized test trials. This information coming from Suzanne Oparil, MD, of the University of Alabama at Birmingham.

The three different trial amounts where:

phentermine 3.75 mg/topiramate 23 mg - 234 patients
                     7.5 mg/46 mg - 591 patients
                     15 mg/92 mg - 1,582 patients

Weight loss resulted from the trials where:
placebo: 1.9%
Low dose: 5.1%
Mid dose: 8%
High dose: 9.9%
(This weight loss was also reported continuous at 56 weeks.)

Blood pressure reduction at 28 weeks was reported at
placebo: 3.06/1.29 mm Hg
Low dose: 5.13/1.64 mm Hg
Mid dose: 6.77/3.05 mm Hg
High dose: 6.51/2.82 mm Hg

The side effects reported through the testing were generally considered mild to moderate which included: dry mouth, diarrhea, dizziness, nausea, fatigue, constipation, headache, back pain, insomnia, tingling, nasopharyngitis, altered taste, and upper respiratory infection. Approximately 20% of patients experienced dry mouth and tingling with the highest dosage at the 28- and 56-week reports.
The patients that had to discontinue due to unfavorable side effects were:

placebo: 8.5%
Low dose: 11.7%
Mid dose: 11.6%
High dose: 17.5%

There was also a change in heart rate reported only at the highest dose with a 1.5 beats per minute increase. The two lower dosages did not report any change in heart rate.

May 13th - 2010

It was announced today that Qnexa will be presented at the 3rd World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy) in Prague, Czech Republic. A presentation will be delivered May 15th named "Weight Loss With Controlled-Release PHEN/TPM Drives Improvement in Comorbidities in Overweight and Obese Subjects."

June 8th - 2010

Positive Results from Phase 2 Study of Qnexa in Obstructive Sleep Apnea Presented at SLEEP 2010, the 24th Annual Meeting of the Associated Professional Sleep Societies (APSS) it is estimated that there are more than 18 million people living with this problem. Obstructive Sleep Apnea (OSA) is said to be increase the risk of stroke, hypertension, diabetes, and sudden cardiac death.
After a 28 week testing period the following was observed:

"Qnexa-treated patients also experienced significant weight loss, reductions in both systolic and diastolic blood pressure, and reductions in respiratory disturbances and improvements in overnight blood oxygen levels. Qnexa treatment was well-tolerated. The most common side effects were dry mouth, altered taste and sinus infection."

July 13th - 2010

An initial review has found Qnexa to be safe and effective, according to a U.S. FDA report released this morning and found "significant" weight loss, however Qnexa may cause certain psychiatric and cardiovascular side effects and has not been adequately tested in pregnant women along with cardiovascular side effects according to U.S. regulators considering the passing of it for market. Study patients taking high doses of the medicine, were four to seven times more likely to stop treatment due to anxiety, depression and sleep- related complications, Food and Drug Administration staff said today. We will have to wait and see what this means July 15th.

July 15th - 2010

In today's vote from the FDA advisory panel the results where 10-6 (one source claimed a vote of 9-7) against its approval. The panel did recognize that the product works well but had concerns over some potential side effects of the likes of birth defects, depression and impaired memory. Vivus, Qnexa's creator, said that it plans to work with the FDA about possible concerns and labeling issues before the official October 28th FDA decision on Qnexa. The FDA usually recommends the advice from their advisory panel however, not always and some feel the vote was close enough thus creating a slight argument that it could still be approved.

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