Vivus Qnexa

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.