Qnexa® - New Prescription Diet Pill

           There is in the works a product named Qnexa® that has been shown to reduce weight in its test patients by significant amounts. Vivus Inc is the company from California that has been experimenting with this combination drug for several years, where they have been fine tuning the amounts and release formulations to produce this trial diet pill. Qnexa consists of the two prescription drugs Phentermine and Topiramate. To some, these products are better known by their trademark names such as Adipex® and Topamax®. Phentermine has been used for years to fight obesity and has worked well. Topiramate has been used as an anti-convulsant such as with epilepsy patients. And although Topiramate has not been approved nor really researched as a weight loss drug, some claim they have lost weight with it as a side effect. However, what Vivus Inc has found is that when combined with each other in specific amounts that the weight loss far exceeds any weight loss that one would find by taking either product alone. Tests are indicating that the safety aspect of Qnexa seems to be right on track for a possible FDA approval. The FDA requires that in order for a drug to be considered as an obesity fighting drug it must have at least a third of its test patients lose 5% or more body weight. Qnexa easily passed this test.

          During various testing phases of Qnexa, these various amounts of each drug combined have been published. The full strength consists of 15mg of Phentermine and 92mg of Topiramate. Medium strength where 7.5mg of Phentermine and 46mg of Topiramate and the lowest dosage used was 3.75mg of Phentermine and 23mg of Topiramate. The Phentermine used was a IR or Immediate Release formulation and the Topiramate was a special CR or Controlled Release. A Warning has been issued however that one should never attempt to mix their own concoction as it could be very dangerous even if you think you have the correct amounts because the release formula would probably be quit different. Also it could be very dangerous simply taking a phentermine pill along with a Topiramate pill because the amounts would be far higher than what would be safe.
          In essence Qnexa acts as an appetite suppressant, decreasing ones hunger and therefore allows one to lose weight more easily. In clinical tests, Qnexa has been proven to help patients lose between 10% and 15% of their body weight over a year's period as well as improve various cardiovascular aspects. Further studies have shown that this mixture has also had good results when studied as a sleep apnea treatment. Sleep Apnea is a disorder where peoples breathing is temporarily interrupted, or stops periodically. Some articles have even claimed that Qnexa could be used as a snoring cure, but it is believed that this information was perhaps distorted slightly as people read that sometimes people with sleep apnea can snore. On that basis, I suppose indirectly that this combination drug could help in that way. Additional studies are also now showing that this drug lowers blood pressure. This is very welcomed news as there have been other diet drugs that have increase blood pressure which makes a less than desired side effect.
          Side effects reported through various testing have generally been deemed acceptable. These include but are not limited to nausea, headaches, dry mouth, insomnia, tingling, altered taste, constipation, diarrhea, fatigue, respiratory infection. Some of these where experienced in some patients, some where not experienced at all. For those who may have experienced any of these, they where generally considered mild to moderate. It will ultimately be in the Food and Drug Administration's (FDA) hands to determine if it feels that the benefits out weight the side effects and if this drug is considered to be safe for a doctor to prescribe to an obese patient.
          A meeting is expected on July 15th, 2010 with an FDA advisory committee to discuss aspects of Qnexa. The results of these discussions may provide which way the panel is leaning in their decision of approval. Final approval or disapproval is expected by late October 2010. However, at this time it could be announced that further testing also be performed in order to clarify any outstanding issues they feel need resolving.
          If Qnexa is approved in the autumn of 2010 or at a further date it would be most likely several months after this when a pharmacy would actually carry it. If it is not approved, it is possible that they either scrap the mixture entirely or start experimenting with different dosages, or release formulas. Anything really is possible as to what might happen if it not accepted. Those decisions would probably hinge on what report was issued by the FDA and then what Vivus Inc decided to do with it.
          A further issue in response to Qnexa's possible approval is availability. Qnexa's main target is that of obese people. To be classified as obese, one needs to have a certain Body Mass Index (BMI) which can vary from doctor to doctor. Chances are that if you don't have a BMI that is in the obese range, your doctor will probably not prescribe it, unless he/she sees other reasons for doing so. It will also probably be recommended that anyone taking it makes lifestyle changes such as ensuring a proper diet and exercise. Prescription diet medication is never to be treated lightly, the reasons a prescription needs to be issued is due not only to its strength but side effect issues. There could be other interactions that one prescription could have with another. Having a doctor helps to ensure overall safety if something does happen to come up unexpectedly.

Frequently Asked Questions

Q: Where can I buy Qnexa?
A: As of yet there is no place where you can purchase Qnexa, it has not yet been approved anywhere so you simply cannot buy it anywhere. There is no pharmacy that has it and no doctor can prescribe it.

Q: When will one be able to buy Qnexa?
A: It will have to be approved by the FDA first. It is expected that the FDA will either reject or approve it October 28th 2010. On this date it was not approved. However it still may go back to the FDA for future approval. Since this time Qnexa has been placed before the European Medicines Agency (EMA) for approval within the European Union. It will then take several months after this to become available in pharmacies, exactly when no one knows yet. You will also need a prescription from your doctor in order to obtain it.

Q: Why not just combine the amounts yourself with generics?
A: This is very foolish and dangerous, not only would you need very precise measuring tools but you still would not have the proper release formats of the medication. You also need a doctor to follow up how the medication is working for you and if any potential hazards are happening.

Q: How overweight does one have to be to use Qnexa?
A: Ultimately it is up to your doctor to decide but generally a Body Mass Index (BMI) of 30 or greater. But there may be some exceptions depending on various factors. This is a general indication only.

Q: If it is approved, would Qnexa be the best choice to inquire about with my doctor?
A: This too is ultimately up to your doctor or health care provider. Talk it over with them to determine if this could be right for you.

Q: What if Qnexa is not approved, where does one turn?
A: You don't need to be concerned because if it is not approved, it would have been determined that it was unfit for the public to be using. Also this is once again up to your doctor. There are other options already in use such as Phentermine, ~~Sibutramine~~ (discontinued) and Orlistat (Alli) talk it over with your doctor/health care provider.

Q: Will I only have to take a pill without changing my diet or exercise?
A: If it is approved, chances are you will be encouraged to have a good diet and partake in a level of exercise that is right for you along with the medication. Ask your doctor about these issues.

Q: What are the chances of Qnexa being approved?
A: If someone wanted to calculate the chances of Qnexa being approved, lets look at past FDA statistics. Apparently, 74% of the time, the FDA will take the advice of its panel of investigators. Also, most medications that include a new active ingredient are also not approved the first time they are reviewed. According to a Booz Allen study, approximately 53% of new medications are rejected, however 43% of these rejections in time are approved.

News

July 15th, 2010
Today an FDA advisory board narrowly recommended that the FDA not approve Qnexa. The vote was 6 to 10 against. Although they admit to its effectiveness, there were some potential safety issues that concerned them. These included possible depression, impaired memory and possible birth effects topped the list. This does not mean that the FDA has yet rejected it; The FDA does not always follow recommendations from their advisory groups but most often does. Vivus CEO Leland Wilson expressed disappointment with the vote but said Vivus plans on working with the FDA to address proper labeling and safety questions. The final decision comes October 28th.

September 21st, 2010
Two year long trail results where made known today and it showed that Vivus Inc's weight loss drug sustained weight loss in most patients for two years and no new side effects where found. Qnexa also showed only small effects on ones heart rate, also issues such as sleep disorders and psychiatric problems where less common in the second year of testing. Patients taking the higher dose of Qnexa for the 2nd year lost an average of 11.4%, patients taking the mid dose lose 10.4% and the placebo group lost 2.5%.

October 28th, 2010
Vivus Inc received a complete response letter from the FDA regarding Qnexa and was informed that it could not be approved in its present form. The FDA requested a comprehensive assessment of topiramate's and phentermine/topiramate's teratogenic potential, which is the potential for disturbing the growth and development of an embryo or fetus. The FDA also requested further studies be performed on the association of the medication on heart rate elevation which could lead to adverse cardiovascular events. Vivus plans on proceeding to compile information regarding these issues. The CEO of Vivus Inc 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." Vivus is expected to submit additional information to the FDA within 6 weeks addressing some of these concerns. While the approval of Qnexa is not certain, there is optimism for an eventual approval, perhaps as early as 2011 since the FDA has not asked for new clinical trials.

-As a side note, their stock (symbol VVUS) jumped as much as 37% on optimism Friday October 29th.

December 14th, 2010
In a continued attempt to obtain regulatory approval of Qnexa, Vivus, Inc. Submitted documentation to the FDA regarding its Complete Response Letter that was delivered October 28th of this year. In that letter, the FDA stated that it could not accept Qnexa in its current form or with the current information it had but needed more information with regards to birth defects and cardiovascular issues. A meeting with the Food and Drug Administration has been arranged in later January 2011 to discuss the details of the new documentation.

December 20th, 2010
Today Vivus filed a European Marketing Authorization Application (MMA) with the European Medicines Agency (EMA) for its obesity drug Qnexa. The EMA is the equivalent of the United States Food and Drug administrations. If all goes well in the European Union, it would be available in potentially 27 European countries by the end of 2011. If approved it could be prescribed for patients with weight related health issues including obesity, type 2 diabetes, hypertension, dyslipidemia, and other weight associated co-morbidities.

January 21st, 2011
In an attempt to lessen any chance of birth defects the FDA today has requested that Vivus Inc investigate if there are any relations between women who have taken Topiramate and cleft palates. Vivus has reported that of the 15 women who where on the Qnexa study who have since given birth have not reported any birth defects.

April 4th, 2011
A two year study's results where released today and it found that Qnexa not only reduces weight but actually reduces blood pressure as well improves lipid levels, and lowered cholesterol, decreased triglycerides by as much as 26%. There was also a 19% decrease in the number of patients who where taking high blood pressure medication during these trials.

The CONQUER study is composed of 2487 overweight patients approx 70% female and 30% male. These people also had high blood pressure, high cholesterol or type 2 diabetes and was performed over 93 different centers in the US. Not only was weight loss of 10% achieved in many patients but the following:

Blood Pressure
- Systolic blood pressure reduction of -4.7mm Hg and -5.6mm Hg for the mid and high dosages. Placebo patients had a drop of -2.4 mm Hg.
- Diastolic Blood Pressure drop of -3.4mm Hg and -3.8mm Hg for the mid and higher dosages compared to -2.7mm Hg for the placebo patients.
- This resulted in more patients reducing their blood pressure medication than the placebo group.

Lipid Levels
-Improvements of HDL cholesterol of 5.2% and 6.8% (mid and higher dosages). The placebo group had a 1.2% improvement.
- Lower LDL cholesterol of -3.7% and -6.9% (mid and higher dosages) compared to the placebo group of -4.1%
- Lower Triglyceride levels of -8.6% and -10.6% (mid and higher dosages) compared to the placebo group where they had an increase of 4.7%.

Metabolic Factors
- Lower fasting insulin levels of -24.0 pmol/L and -27.5 pmol/L as compared to an increase of 5.1 pmol/L for the placebo patients.
- Patients in the placebo group had an increase in the number of antidiabetic drugs compared to each Qnexa group.
- Fewer Qnexa patients progressed to type 2 diabetes than compared to the placebo group.

September 15th, 2011
The FDA has agreed to an early resubmission of Qnexa by the end of October 2011. As a result, the FDA could make a decision by the end of the 2nd quarter.

October 17th, 2011
Vivus Inc, has resubmitted Qnexa to the FDA with a warning along with the medication that it should not be taken by women who are capable of having children due to concerns about cleft palate birth defects. An FDA panel advisory will review this application in the first quarter of 2012 with a final decision by the FDA is expected in the 2nd quarter of 2012.

November 3rd, 2011
The FDA has accepted Vivus's NDA (New Drug Application) re-submission of Qnexa for weight loss and have given it a 5 month review period. There will still be an advisory committee meeting sometime in the first quarter of 2012 however, the FDA has set a deadline for an actual decision on accepting or declining Qnexa is April 17th, 2012.

December 21st, 2011
In news today Vivus reported that the ingredient topiramate, found in their weight loss drug Qnexa, is linked to birth defects, specifically cleft lip or palate. While it had been suspected since the FDA brought up the possibility around a year ago, now clinical data does show there is a slight correlation. The data showed that women who toke topiramate during their first trimester of pregnancy would be twice as likely to have a baby with cleft lip or palate. There however was not a problem found if a woman took topiramate before becoming pregnant. The numbers for topiramate users during their first trimester was a 0.36% that they would give birth to a baby with cleft palate compared to 0.16% (former users of topiramate) These numbers came from over 15,000 past medical claims and not specifically from direct clinical trials using Qnexa. In past months however Vivus already recognized this possible issue and stated they would pursue this medication but give a warning / restriction for women who are in child bearing years.

December 23rd, 2011
Today Vivus was informed by the FDA that an advisory committee meeting is scheduled for Wednesday Feb 22nd 2012. It the meeting, the advisory committee members will give their opinion and vote whether they recommend Qnexa or not. This will only be their recommendation for the FDA. In most cases the FDA will take the advice of their advisory committee but not always. The FDA decision is still expected to take place Tuesday April 17th, 2012.

January 9th, 2012
After discussions with the FDA, Vivus has been asked to remove the contraindication (inadvisable treatment) for women of childbearing possibility in their projected label of Qnexa. The treatment would remain restricted for pregnant women. This proposed labeling would help Qnexa to reach a larger patient population. As a result, Vivus Inc, is revising its proposed risk evaluation and mitigation strategy based on the change for its meeting in February. While this news initially looks favorable for Qnexa, it also allows the FDA to now ask for more time to review the application.