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A Promising New Diet Drug

Update:
QsymiaŽ was approved by the FDA for the treatment of obesity July 17th, 2012
It was formerly known as QnexaŽ

          The United States is watching with great interest an application by the drug manufacturer Vivus Inc, for registration of a new drug which promises to assist obese patients to lose weight effectively, namely QsymiaŽ. In the patients who have taken the drug in clinical trials, the drug has been shown to work better than other drugs used for the same purpose, the patients losing between 10% and 15% of their body mass within a year. QsymiaŽ acts as an appetite suppressant, assisting patients to manage their urge to eat more than what their bodies need. In addition, it appears to have beneficial effects on the cardiovascular system. It lowers blood pressure. This is of great importance as hypertension affects most overweight people. Yet another beneficial effect observed with QsymiaŽ use was an alleviation of sleep apnea. Interestingly, this effect was first noticed when subjects reported that taking the drug resulted in a diminution of their snoring: further investigation revealed that the actual effect of the drug was the relief of the sleep apnea which had been the origin of the snoring.



          The components of QsymiaŽ are not new. The drug is a combination of two known drugs, in use for some years: when combined they have been found to have a profound effect on the appetite of the subjects.  One of the drugs in the combination is phentermine, marketed under the trade name Adipex, which has been known for some time to diminish appetite. The other is topiramate, marketed as Topamax. The latter has not in the past been used as an appetite suppressant: it is registered for use as an anticonvulsant, so is widely used in epilepsy, among other conditions resulting in convulsions. The interesting thing is that combining these two medications has the effect of enhancing the appetite suppressant action of phentermine.
          The Food and Drug Administration (FDA) needs to grant approval for the use of QsymiaŽ in the treatment of obesity, as in spite of the fact that phentermine has been registered for this use for some time, topiramate has not. The FDA examines various factors prior to deciding whether to grant registration for a drug or not. One of the factors is the efficacy of the medication, and the other is the risk associated with the side effects. After all, it is the function of the FDA to protect the interests of the nation regarding the safety of the medicines approved for our use.
          The first application for registration by the FDA was rejected in July 2010. The company then performed additional testing in order to provide clarifying information on certain aspects of the drug. A second application was made, and the advisory group has recommended that the registration be approved: this decision is due to be announced in July 2012. The nation's obese are holding their collective breaths, and hoping that a drug that holds such promise will be granted approval to be prescribed.
          Regarding the side effects, these have been described as generally minor and manageable. Some patients have reported some nausea, dry mouth, an altered sense of taste, diarrhea, constipation, headaches, fatigue, and there also appears to be a higher incidence of respiratory infection in the test subjects.  In view of the fact that QnexaŽ reduces blood pressure, whereas most other diet drugs increase it, and the fact that it is so effective in bringing about weight loss, the mild nature of the side effects, which are only experienced in a few subjects, could be regarded as a small price to pay for an effective medication.
          Should the FDA grant approval for the registration of QsymiaŽ to be prescribed in the management of obesity, this will be another item in the armory that medical practitioners can use against obesity. It will be a relief both to the medical professionals and the patients to know that this effective and safe medicine in available.
          A doctor would then be permitted to prescribe it for obese patients. There is more than one definition of what constitutes obesity: but generally it is taken to mean a body mass index of 30 or more. It would then be prescribed together with a sensible, calorie-reduced eating plan and also a suitable exercise regime.
          The question could be posed whether it would be possible for a doctor to prescribe the components separately, should the FDA not grant approval for its registration. It is known that QsymiaŽ would, in the case of approval, be available in three strengths: the lowest dose would contain 3.75mg phentermine and 23 mg topiramate; the medium dose would contain 7.5 mg phentermine and 46 mg topiramate; and the maximum dose, 15 mg phentermine and 92 mg topiramate. With these proportions known, it is argued by some, the treating physician would be able to prescribe the two main ingredients separately so that the patient would be able to benefit from the appetite-reduction effects by another means. However, there are always risks associated with the medical profession and/or the patients embarking on such steps. It would be too easy for a miscalculation to occur, or for a patient to make an error in taking the correct combination of the correct doses. Also, each of the active ingredients in would be present in a special form: the phentermine in an immediate-release form and the topiramate in a controlled-release form. It is important that these be taken by the patient in the correct formulation, or otherwise the desired beneficial effects could be diminished and/or the unwanted effects enhanced. Also, Vivus found during testing that the combination of the correct formulations, which thus resulted in the correct bioavailability, resulted in a greater weight loss than was evident when the two active ingredients were taken separately.
          Another risk related to self-medication in this fashion is that the risk of drug interactions is always increased when other medication is used simultaneously. It is thus safer for the patient to use a drug which has been tested thoroughly for drug-drug interactions in the form in which it would be prescribed, rather than to embark on untested territory.
It is important that medical professionals warn their patients of these risks. Many people acquire information about medication that could help them with a health problem; and many will embark on risky practices as they are not aware of the dangers that they face.
Thus, should the FDA grant approval for the use of QsymiaŽ, it will be a prescription drug, only available through drug stores: and will only be used for patients whose degree of overweight is such that they can be classified as obese - not for the person who only needs to lose a couple of pounds. Even though the side effects and the risks related with the drug are minimal, there is nevertheless always some danger associated with the use of any medicine. The supervising physician will also incorporate the other components of a weight management program such as diet and exercise.

Frequently asked questions

Q: How safe is QsymiaŽ?
A: The manufacturer state that it has been found in clinical trials to be a safe medication. However, the FDA is tasked with checking that the manufacturer's claims are accurate, and so will review all the evidence and make an announcement in this regard.

Q: Where can I buy QsymiaŽ?
A: At the moment it is not available for sale. Until the FDA approves it for use, it is not available to the public: it has until now only been used in carefully-controlled clinical trials.

Q: When will I be able to buy it?
A: It was just approved so it will probably be quite a number of months before it finds its way onto the drugstore shelves. The manufacturer would need to get ready for mass production of the drug, and then distribute it.

Q: What are the chances that the FDA will approve it?
A: Already has been.

Q: Will this by itself solve my overweight problem?
A: No, no medicine alone will get rid of your excess weight. You will have to embark on a lifestyle change, in which a sensible eating pattern and suitable levels of exercise are included.

Q: Can I take the two ingredients separately?
A: No, this is not recommended. Firstly, the form in which the active ingredients have been manufactured affects the way they are released into your bloodstream and thus the way they are taken up and used by your body cells. If you take the active ingredients separately you will not enjoy the beneficial effects of QsymiaŽ, and you expose yourself to various risks because the formulation is not exactly the same.


Š 2012