What is Qsiva?
Qsiva is the European name for Qsymia, an appetite suppressant approved in the United States. An application for Qsiva was rejected by the European Medicines Agency but it is likely that a new application will be submitted with further information taken from post-marketing studies in the United States. Qsiva has been developed by Vivus, a fast-growing pharmaceutical research company based in North America. If Qsiva is licensed in the EU then this is unlikely to happen before 2015. Qsiva is designed to help obese patients reduce their appetite and feel satisfied with less food. It comes in capsule form and is taken daily.
How does Qsiva work?
Qsiva contains two active ingredients, phentermine and topiramate. Phentermine used to be a commonly prescribed slimming medication until about a decade ago, when concerns were raised about its impact on long-term health and whether it is addictive. Phentermine is no longer generally prescribed in the UK but there are some specialist slimming clinics that prescribe this medication for very short-term use. Phentermine is still the most commonly prescribed weight loss medication in the United States. Topiramate was approved in 1996 as a treatment for epilepsy and more recently as a treatment for migraine prevention.
Topiramate works through GABA receptors in the brain to increase feelings of satiety and fullness. Phentermine stimulates the release of the neurotransmitter noradrenalin, which reduces appetite. The combination of Topiramate with Phentermine appears to increase Topiramate's window of effectiveness.
Is Qsiva effective?
Qsiva has gone through two separate phase III clinical trials required by the FDA and results from the trials indicated that it is an effective aid to weight loss in obese patients.
In the EQUIP trials, lasting 56 weeks and involving 1,267 obese patients, data showed that:
- On average patients taking the drug at full strength lost 14.7% of their body weight, compared with 2.5% for those on the placebo over the 56-week period
- 84% of patients on the highest dose lost 5% or more of their total body weight, with 59% on the lower dose achieving the same results, compared with only 26% in the placebo group achieving the same result
- Average weight loss for the high-dose group was 37 pounds, 18 pounds for the low dose group and 6 pounds for the placebo group
In the CONQUER trials, involving 2,487 patients with co-morbidities such as high blood pressure, Type 2 Diabetes and high cholesterol, the results were as follows over a 56 week period:
- Patients lost 13.2% of their total body weight on the high dose, 10.5% on the lower dose and 2.4% on the placebo
- 85% of patients on the high dose and 75% on the lower dose lost 5% or more of their body weight, compared with 26% in the placebo group
Is Qsiva safe?
As with any medication, Qsiva does seem to have some side effects in some patients. The most common were dry mouth, tingling sensations, constipation, altered taste and insomnia. The medication did not seem to cause problems with mood, depression or suicidal ideation.
There had been concern about side effects reported previously with Phentermine - raised blood pressure - and Topiramate, namely cognitive problems and depression. However both drugs are present in Qsiva in very low doses and there has been no indication in the clinical trial data that the medication causes any of these, or any other, serious side effects.
The Online Clinic has always opposed the prescription of Phentermine on its own but if this new sustained release formulation in combination with Topiramate is deemed to be safe and effective then we will give serious consideration to prescribing it once the medication has been approved by the European Medicines Agency and the MHRA.
When will Qsiva be available?
Qsymia is available in the United States through certain physicians but it cannot be bought online. If a European license is again applied for, we would expect Qsiva to become available in 2015 in the EU.
Register your interest in Qsiva
Although we cannot prescribe Qsiva at the moment, if you register for a weight loss consultation now and agree to be on our mailing list then we will notify you as soon as Qsiva becomes available.
Qsiva (formerly known as Qnexa and Qsymia in the US) has been denied a license by the European Medicines Agency following the appeal by Vivus. Vivus (the patent holder) requested a re-examination of the evidence and we believe that they put together a risk mitigation strategy similar to the one…Read full article >
We previously reported that Vivus Inc did not feel confident about its obesity treatment, Qsiva (previously known as Qnexa) being approved for marketing in the EU. Therefore, we are not surprised to hear that Qsiva has now received a negative opinion from the European Medicines Agency. Although…Read full article >