The new anti-obesity drug contains two proven pharmaceutical ingredients, Phentermine and Topiramate. Each of them was approved by FDA separately:
- Phentermine – in 1959 (for obesity treatment)
- Topiramate – in 1996 (for seizures control)
Topiramate and Phentermine combination was used for therapeutic purposes only after it has been proven. This combination therapy helps achieve significant weight loss.
Given that Qsymia drug contains two active ingredients, it is characterized by dual mode of action. Qsymia helps to lose weight because:
1. Phentermine – suppresses appetite
2. Topiramate – increases satiety feeling.
Qsymia is manufactured as extended-release (ER) capsules, which gradually release active ingredients Phentermine and Topiramate, and thereby provide a prolonged anorectic effect.
Dual mechanism of action, combined with long anorectic activity, provide effective appetite control from morning till evening, and fast weight loss by reducing calorie content of the daily diet.
Clinical research results have shown that using Qsymia for one year:
- About 40% of patients have lost at least 10% of the initial weight
- About 60% of patients have lost at least 5% of the initial weight
Uniqueness of Qsymia drug is the mutually complementary anorectic effect of active ingredients. Qsymia capsules contain low doses of Phentermine and low doses of Topiramate.
Therefore, Qsymia is characterized by high efficiency and relatively few side effects.
The list of the most common side effects of Qsymia includes:
- dry mouth
- distorted sense of taste
- numbness and tingling
- sleeping disorders
Other adverse reactions are observed in less than 5% of obese patients.
Qsymia does not cause serious side effects, so for most obese people benefits of its use outweigh its potential risks.
Particular attention should be paid to the fact that in addition to weight loss, patients taking Qsymia may experience:
- drop in blood pressure
- reduction in triglycerides
- reduction of waist circumference
- slowdown of type 2 diabetes progression
- improved cardiometabolic risk factors.
Each of the additional benefits was demonstrated by the results of long-term clinical trials.
Qsymia drug is normally well tolerated by different groups of patients and can be used to treat obesity complicated by concomitant risk factors.
- Patients diagnosed with excessive weight and diabetes, hypertension, dyslipidemia, or other chronic diseases, can start treatment with Qsymia if their BMI is 27 or more.
- If no risk factors usually accompanying obesity are observed, Qsymia-therapy can only be indicated if the obese patient’s BMI equals or exceeds 30.
Qsymia is not approved for obesity treatment in children, but perspective clinical studies of Qsymia application for obesity treatment in children and adolescents are continuing.
For obesity treatment in adults, Qsymia capsules containing a fixed dose of the active ingredients are used. Each Qsymia capsule may contain:
- 3.75mg, 7.5mg, 11.25mg, or 15mg of Phentermine
- 23mg, 46mg, 69mg, or 92 mg of Topiramate
In 2016, the US market is supplied with:
- purple capsules of 3.75mg /23mg Qsymia
- purple-yellow capsules of 7.5 mg /46mg Qsymia
- yellow capsules of 11.25 mg /69mg Qsymia
- yellow-white capsules of 15mg /92 mg Qsymia
Different concentration of the active components is required to gradually increase and adjust the optimal daily dose of Qsymia.
- The minimum initial dose of 3.75mg /23mg Qsymia should be taken once daily, in the morning (one purple capsule), for the first two weeks of anti-obesity therapy.
- On the fifteenth day of treatment, the morning dose of Qsymia should be increased to 7.5 mg /46 mg (one purple-yellow capsule).
The increased dose of Qsymia should be taken continuously for three months, and then the treatment effectiveness to be evaluated.
If in 3 months after the start of application of purple-yellow Qsymia capsules, the body weight is decreased by less than 3%, this drug should be canceled, or the daily dose of Qsymia should be increased.
At the second stage of obesity treatment, the morning dose should be increased to one yellow capsule of 11.25mg /69mg Qsymia. This dose should be taken daily for two weeks. Then, a single dose should be increased to one yellow-white capsule of 15 mg /92 mg Qsymia.
- If in 3 months after the start of application of the maximum Qsymia dose of 15mg /92mg, the body weight decreased by less than 5%, Qsymia drug should be canceled.
- If achieved results demonstrate weight loss by more than 5%, application of yellow-white capsules of Qsymia can be continued.
The clinical research results show that most obese patients using Qsymia managed to achieve significant weight loss in just 5-6 months.
If Qsymia provides stable weight loss, but the desired result failed to be achieved for six months, Qsymia can be used for long-term anti-obesity therapy, for up to 1 year.
Qsymia is the only Phentermine-containing drug approved by FDA for long-term treatment of obesity. Other weight loss drugs containing Phentermine (including Adipex-P, Suprenza) are approved for short-term anti-obesity therapy lasting up to three months.
Today, Catalent Pharma is the exclusive manufacturer of Qsymia, but its capacities are not ready to expand the marketing of diet pills. So if Qsymia (Qsiva) is approved in Europe, Vivus will have to enter into partnership with other manufacturers of pharmaceutical products.
Another company involved in Qsymia commercialization in the USA is Cardinal Health. The company provides Vivus with logistics services.
From 2015, Vivus promotes Qsymia in USA in collaboration with:
- Privately held biopharmaceutical company – Kadmon Corporation
- Nonprofit medical practice and medical research group – Mayo Clinic
Despite that Qsymia is available in USA only for few years, two pharmaceutical companies (Actavis and Teva) are trying to challenge patent exclusivity for the drug.
In the second quarter of 2016, Vivus is an owner of 12 patents for Qsymia in the USA, and 4 patents are pending so far. Actavis and Teva challenged the most patents for Qsymia, in order to obtain approval to manufacture and sell generics of Qsymia in the USA.
If Teva and Actavis successfully challenge the patent exclusivity for Qsymia, the first generics of Qsymia may appear on sale already in 2017-2018 years.
If Vivus proves its exclusive patent rights for Qsymia, it will remain the sole rightholder for Phentermine/Topiramate-containing drug till 2020 as minimum.
Qsymia investigations are continuing and Vivus hopes that this combination drug may be useful in treatment of not only obesity, but also of concomitant diseases of obesity, including:
Despite its high efficiency, proven safety and other advantages of Qsymia, this drug has one disadvantage – its high price.
The cost of diet pills that contain only Phentermine is lower than the cost of combination drug Qsymia (Phentermine and Topiramate). Therefore, between Qsymia and Phentermine, many Americans with overweight select cheap Phentermine pills.
In order to successfully compete with other manufacturers of weight loss products, the US provider of Qsymia provides:
- To get first 14 capsules of Qsymia for free
- To get a monthly discount of 75$ for every 30 capsules of Qsymia
Popularity of Qsymia in USA is growing and the number of prescriptions for this drug increases annually.
- In 2013, more than 370,000 prescriptions for Qsymia were issued
- In 2014, more than 530,000 prescriptions for Qsymia were issued
- In 2015, more than 560,000 prescriptions for Qsymia were issued
Since the launch of sales to mid-2015, about 1.3 million prescriptions for Qsymia were given to more than 300,000 obese men and women.
Considering that about 110 million people with overweight or obesity live in the USA, the number of Americans using Qsymia will be growing.
The first sales of Qsymia started in 2012, but the drug history began much earlier.
The first patent for a combination product containing Phentermine and Topiramate was issued to Dr. Najarian, in 1999.
Dr. Najarian proved that benefits of combination of Phentermine and Topiramate for weight loss are higher than in application of each of these pharmaceutical agents individually.
In 2001, Dr. Najarian and drug-development company Vivus signed an agreement on transfer to Vivus of all rights for further development, investigation, and commercialization of the combination product containing fixed doses of Phentermine and Topiramate.
After years of laboratory researches and clinical observations, Vivus proved that benefits of the combination of Phentermine and Topiramate for obese patients outweighed the potential risks.
After studying these research results, the FDA approved Phentermine and Topiramate for long-term weight control, and in 2012 for the first time this combination drug was launched for sale under brand name Qsymia.
In 2015, more than 60% of Qsymia consumers used the money-saving program, bought Qsymia at a discount and (or) got free Qsymia for 14 day course.
In 2016 money-saving program is continuing, so you can still get a free trial of Qsymia, or buy Qsymia monthly at a discounted price.
It should be noted that Vivus was trying to get the central marketing authorization for Phentermine /Topiramate pills in Europe, but in 2013 the application was rejected. In the EU, Vivus planned to sell a new drug under brand name Qsiva.
After studying the research results, the European Medicines Agency concluded that Qsiva could create potential risks to the central nervous system and the cardiovascular system.
Therefore Qsiva (Qsymia) sales in Europe were not launched, although attempts to obtain a European license for this product are still ongoing.
It should be noted that all rights for Qsymia belong to Vivus, but the company has not its own pharmaceutical factory. Therefore Vivus is manufacturing Qsymia in partnership with Catalent Pharma Solutions.
Qsymia is an anorexiant (appetite suppressant) used to treat severe cases of obesity that can potentially cause weight-related health problems like diabetes, high cholesterol, hypertension and heart diseases.
Two basic components are used in the drug’s capsules – Phentermine and Topiramate. The former is a well-known appetite suppressant many weight loss medications are based on.
The latter is an anticonvulsant, the drug often referred to as a seizure medication. Combined in the formula of Qsymia these work for the weight loss objective.
Recommendations for Use
Qsymia is never recommended as the only solution to the problem of excess weight; it is always an additional component used in the overall weight loss program. The other two are regular exercises and healthy (low-calorie) food.
Qsymia capsule is taken once a day, in the morning preferably. The strength is based on the weight-height correlation, your medical condition and overall response to the treatment. Capsules are to be taken whole (no chewing, crushing, opening), with or without food.
Therapy with Qsymia: Precautions
Therapy with Qsymia requires responsible attitude. On the one hand, you must follow all the recommendations given. On the other, understand all potential risks the drug can involve before you get a prescription.
Thus, Qsymia is contraindicated for patients with:
- glaucoma and overactive thyroid;
- pregnant women come into this category as well.
Patients with such concomitant conditions as:
- heart problems,
- kidney and liver diseases,
- metabolic acidosis,
- seizures or epilepsy,
- mental illness
- history of depression
also require monitoring if and when on therapy with Qsymia.
Qsymia Side Effects: How to Avoid
Potential side effects may include the following symptoms: change in or loss of taste, stuffy or runny nose, sneezing, ear congestion, back pain, rash, itching, sweating, headache, dizziness, nervousness, fear, memory problems, etc.
More serious reactions that require immediate medical aid can be the following: chest discomfort, irregular or racing heartbeat and pulse, nausea, vomiting, shortness of breath, convulsions and some others.
To prevent any you must: