Information on new prescription diet pills

Qsymia® (Formerly Qnexa®)

           There is in the works a product named Qsymia® (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 Qsymia (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.
          The FDA advisory committee July 15th, 2010 voted against its approval thus leading to the rejection in October 2010. After this time further testing was performed in order to clarify some outstanding issues that needed resolving. In Feb 22nd 2012, the FDA's advisory group voted in favor of approval 20-2.  The FDA will decide if they go with this advice and approve Qnexa on April 17th, 2012, Now extended to July 17th, 2012.
          If approved, 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. It's particularly critical to inform your doctor about any blood clotting meds that you are taking if you plan to use diet pills as there are
side effects of Pradaxa and other drugs that may mask the complications of the prescription diet pills. Having a doctor helps to ensure overall safety if something does happen to come up unexpectedly.























Frequently Asked Questions

Q: Where can I buy Qsymia (Qnexa)?
A: As of yet there is no place where you can purchase Qsymia (Qnexa), it is not yet on pharmacy shelves but soon will be!

Q: When will one be able to buy Qnexa?
A: It will have to be approved by the FDA first.
Which it was July 17th, 2012! The FDA first rejected it on October 28th, 2010 but the FDA on Feb 22nd, 2012 had another advisory panel vote that was 20-2 in favor of approval. The FDA will have a meeting July 17th 2012. It looks like it will be approved this date as they usually take the advice from their advisory panel. But they do not always follow its advice. 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 Qsymia (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 Qsymia (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: No need to worry now, this has been approved.

Q: Will I only have to take a pill without changing my diet or exercise?
A: 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: Again, old question, it has been approved. 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


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July 17th, 2012
Qsymia® has officially been approved for the treatment of obesity. Qsymia® is now the new name for the drug Qnexa®  This is the same medication but it is just under a different name. This new name was announced with the FDA's approval of their generic Phentermine and Topiramate cocktail. The FDA approved it after seeing how effective it was and while there are some side effects, it is still considered safe for the general overweight public. However, one issue that was addressed was that of birth defects. It looks like the FDA is placing warnings about this and is requiring that women take birth control if taking Qsymia.
In an attempt to prove its cardiovascular safety, Vivus Inc plans on doing post approval clinical studies with patients to ensure its longer term effects are safe. This approval comes after it was initially denied in 2010 due to safety issues. But after further research in early 2012 the FDA's advisory panel committee recommended that it be approved.

June 5th, 2012
Vivus Inc released today that they have delayed their meeting with the European regulatory committee in order to better prepare for it. The hearing with the EMA's (European Medicines Agency) CHMP (Committee for Medicinal Products for Humana) will now take place in September. This will be an oral hearing with is proper protocol with the CHMP.

April 9th, 2012
Today the FDA informed Vivus Inc, that the initial date of April 17th, 2012 to review Qnexa has been extended by three months. The new date for the review is now July 17th, 2012. The reasoning is that on April 4th, 2012 Vivus had submitted a Risk Evaluation and Mitigation Strategy (REMS) to the FDA. This is considered an modification to the New Drug Application. Because this happened within three months of the initial PDUFA (Prescription Drug User Fee Act) that was suppose to be April 17th, 2012 the FDA extended it three months. The three month extension is a standardized time period the FDA assigns when additional risk management information is provided.

Febrary 22nd, 2012
The FDA's panel advisory board voted 20-2 in favor of approving Qnexa
for the treatment of Obesity. This is a vast difference in the vote from 2 years ago, but since then further information and testing was made known. This vote doesn't come with certain concerns and as such, if approved, it is most likely a post study will be done. Stay Tuned April 17th for the FDA's ultimate decision.

February 16/17th, 2012

Tomorrow the results of the FDA internal review of Qnexa will be released. The FDA will propose questions with this review that the independent Advisory Panel will discuss. This will be brief in nature and is meant as a prelude to the Advisory Panels recommendation come Feb 22nd. Some issues that will most definitely be brought up are those surrounding issues of Major Adverse Cardiac Events (MACE) such as Strokes, Cardiovascular, heart concerns including heart rate changes, blood pressure etc. The cleft palate issue will most assuredly be raised. What makes all of this interesting is that March 28th-29th 2012 the FDA is going to be discussing cardiovascular safety issues of weight loss drugs. There is the chance that there could be more restrictions put into place that would jeopardize the advisory panels opinion anyways.

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.

2011
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.

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.

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.

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.


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.

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.


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.

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