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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.
April 9th - 2012
The FDA has informed Vivus Inc, that the Prescription Drug User Fee Act (PDUFA) date of April 17th, 2012 has now been pushed to July 17th, 2012. April 4th, Vivus has submitted additional information to the FDA in the form of a Risk Evaluation and Mitigation Strategy (REMS). Since this is an alteration in the NDA, the FDA added on three additional months to allow a proper and full review. The three month extension period is a standard time extension if additional risk management information is supplied so close to the original due date.
Feb 22nd - 2012
The FDA's panel advisory committee has voted their opinion on whether they think it should be approved and an overwhelming yes vote prevailed. The vote was a 20-2 in favor to approve Qnexa for the treatment of obesity. On April 17th, 2012 the FDA will take into consideration this vote when they make their decision on approval or not.
Due to certain cardiovascular concerns it is probable that post follow up studies will be completed in order to keep a watchful eye on any possible problems.
Feb 21nd - 2012
Tomorrow is when the FDA's advisory panel will let us know their opinion on whether they believe Qnexa should be approved or not. While the FDA most often takes the advise of their advisory panel, they don't necessarily and are under no obligation to do so. They will most likely have questions about Major Cardiac Events (heart concerns) As well, the side effects directly related from Topiramate, in particular cleft palate concerns. Stay tuned for their findings.
January 9th - 2012
In a response from the FDA, Vivus has removed the proposed restriction label for Qnexa for women of child bearing potential. The restriction will still remain for pregnant women. Initially Vivus had put on a contra-indication for women in childbearing years. But the FDA has since told them to remove this. Investors saw this as a positive as the stock gained in the teen percentage points but this is still hard to determine what the final decision will be on the approvability of Qnexa in an upcoming advisory meeting on February 22nd 2012.
December 23rd - 2011
The FDA has told Vivus that an advisory meeting will take place Feb 22nd 2012. In this advisory meeting, the members will vote on whether they would recommend this drug be approved or not. The resulting vote will only be used as a recommendation for when the FDA will make its decision on the scheduled day of April 17th, 2012. In most cases the FDA will listen to its advisory council and act accordingly but not always, as was the case just recently with Contrave.
December 21st - 2011
Vivus confirmed that the ingredient Topiramate, one of the ingredients in Qnexa, does have a link to cleft palate/lip. While this has been the belief since the FDA brought up the point back when Qnexa was originally under the microscope on whether it would be approved or not, today it was officially announced. Women who had taken Topiramate in their first trimester of pregnancy had twice the chance of having a baby with a cleft palate. This equates to a 0.36% chance compared to the regular 0.16%. This information however does not point to any correlation between a woman who had taken Topiramate and then discontinued it before becoming pregnant. While this news is not necessarily encouraging, Vivus some time ago did mention that they would not recommend that Qnexa be used for women who are in their child bearing years.
November 3rd - 2011
The New Drug Application (NDA), that Vivus submitted October 17th of this year for Qnexa for the treatment of obesity, has been accepted. The FDA has given a review period of 5 months in which to discuss the various aspects of this medication with use for weight loss. The FDA has also given a deadline of April 17th, 2012 for their decision on the acceptance or rejection of the drug.
October 17th - 2011
Earlier in September Vivus Inc mentioned they would be working to resubmit Qnexa before the end of October of 2011. Then it was reported today that they have indeed resubmitted it but with the added warning that it should not be prescribed/used for women who are capable of having children due to possible concerns with cleft palate birth defects. As a result the FDA will have a panel advisory meeting expect in the 1st Quarter of 2012. The final FDA decision will most likely come in the 2nd Quarter of 2012.
April 4th - 2011
Vivus released information today about a two year study and found that Qnexa actually helped to reduce blood pressure, improve lipid levels in addition to excellent weight loss. During this study, it was found that of the patients receiving medication for their high blood pressure, 19% of them could discontinue it compared to a placebo.
January 21st - 2011
The FDA has requested that Vivus run an investigation on whether women who have taken Topiramate, mentioning for migraine headaches, have a higher chance of giving birth to children with oral cleft (cleft palate). Vivus has noted that of the 15 women who have since given birth while previously taking part in the Qnexa trials have not had any incidences of birth defects.
October 28th - 2010
Vivus Inc, announced that the FDA has issued them a complete response letter informing them that it cannot accept Qnexa in its current form. However, the FDA requested that Qnexa undergo further testing in particular for issues regarding the medications possible interference with embryonic and fetal growth along with possible negative heart rate influences on cardiovascular health. Vivus plans on addressing such issues and carrying out further testing to prove their product. Chief Executive Officer of Vivus stated "We remain confident in the efficacy and safety profile of Qnexa demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity"
September 21st - 2010
The results of a 2 year study on the effects of Qnexa was released today and Vivus said the data demonstrates the medication's safety. There was no issues of any suicidal thoughts and any effects on the heart where very small, they also stated that issues such as cognitive memory, sleep issues and depression where actually less common during the second year. These issues where questioned by various FDA panel members back on July 15th of this year. The long term weight loss also showed much promise as 675 patients taking the higher dose of Qnexa for the second year lost 11.4% and a mid dose group lost 10.4% (compared to 2.5% for the placebo group).
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.
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.
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."
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."
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:
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:
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.
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."
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.
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.
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 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.
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.
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 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.
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 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.
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%.
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.
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.
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.
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Qnexa® is the brand name of the medication produced by Vivus. Qnexa is a combination drug of topiramate and phentermine being studied for the treatment of obesity.
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