New Drug Highlights
A great many people are excited about Savella: sufferers of fibromyalgia, their families, loved ones, employers, and physicians. But while the FDA approval has generated excitement, some are skeptical, and wonder if the drug is really safe and effective. There’s some validity to being cautious about a new addition to the pharmacists’ stock of drugs to treat fibromyalgia, but there’s not much point to being worried and concerned. It makes more sense to study up and find out on your own if Savella is worth trying. The manufacturers believe the drug will be on the pharmacists’ shelves in March 2009, so now is a good time to look at the issues and come to some conclusions.
No Lab Tests
The nature of fibromyalgia is that it eludes any standard measuring process for obtaining conclusions about a worsening or an improvement of the patients’ symptoms. There aren’t really any laboratory tests, for example, that indicate the patients’ status regarding their pain and fatigue. Physicians must rely in heavy measure on what their patients have to say about their own symptoms.
Perhaps this is why the clinical development program for trials on Savella was designed in a unique manner which revolved around the patients’ assessments of their own symptoms. For these trials it was deemed necessary that individual patients show improvement in their symptoms according to a numbered scale. The patients’ input in how they felt was considered to be crucial to the analysis of the medication. To this end, patients rated their own wellbeing with regard to three different issues: impressions of pain according to a visual analog scale, global assessments or impressions of any change in general wellbeing, as well as any progress made in terms of physical function.
In the course of the two U.S. Phase III clinical trials on Savella, 2,084 patients took part with 1,460 of them using Savella, and another 624 of them taking a placebo. A significant improvement was seen in those patients who took the medication as opposed to those treated with the placebo. The first of these trials lasted 6 months, and the second trial lasted a total of 3 months.
In each of the two studies, the majority of the patients being treated with either 100 mg. or 200 mg. per day of Savella (as opposed to those treated with the placebo) reported a 30% reduction in pain and described their condition as either “very much improved” or “much improved” after three months of treatment. The vast majority of those participants in the Savella treatment group achieved improvement in their levels of pain, physical functioning, and patient global assessment meeting the primary endpoint or goals of the trials. In both trials, some patients who were self-described as “much” or “very much” improved achieved a measure of pain reduction within the very first week of treatment.
The clinical trials appear to have given ample demonstration that Savella is both safe and easy to tolerate. However, the long-term effects of Savella are outside the parameters of these short-term studies. The main adverse reaction to the drug was found to be nausea. Other common reactions to the medication during the clinical trials included: constipation, hot flashes, excess sweating, vomiting, palpitations, increased heart rate, dry mouth, and hypertension. In general, these reactions were reported as mild or moderate in nature.