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.
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.
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.
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,
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.
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