Second Phase III Trial
Jazz Pharmaceuticals is feeling very hopeful about the early results of trials for its latest fibromyalgia treatment, sodium oxybate (JZP-6). So far, the preliminary results from the second Phase III trials on the drug have been nothing but positive. The company is holding a controlled study with placebos for sodium oxybate to see if it continues to achieve its main objectives. Earlier random and double-blind trials proved that sodium oxybate reduced both pain and fatigue. The drug also appeared to improve everyday functioning and patients reported that their quality of living improved during treatment.
I. Jon Russell, M.D., Ph.D., Associate Professor of Medicine, Division of Clinical Immunology and Rheumatology, as well as the Director of University Clinical Research Center at the University of Texas Health Science Center in San Antonio served as point man for the first of the two Phase III trials for sodium oxybate. Russell stated that, “Fibromyalgia is a chronic illness, characterized by widespread pain, unrefreshing sleep, chronic fatigue, and psychological distress. Sodium oxybate has shown a positive effect on a number of the symptoms of fibromyalgia, and thus could have a significant impact on patients’ quality of life.”
The second round of Phase III trials will take place in the United States as well as in seven EU countries over a 14-week period of time. A total of 573 fibromyalgia patients will participate in the study and be treated with sodium oxybate 4.5 g, sodium oxybate 6 g, or a placebo. The regulatory bodies for both the EU and the US are looking to see what percentage of participants achieve a minimum of a 30% reduction in their pain by the end of the trial.
Participants will be assessed according to the Pain Visual Analog Scale (VAS). In the EU, data generated by the Fibromyalgia Impact Questionnaire (FIQ) are considered to have comparable relevance, whereas FIQ data is considered by US regulators to be supportive rather than of primary importance.
As of now, patients treated with sodium oxybate are achieving that magic number of 30% reduction of pain as compared to those being treated with the placebo. Actually, both groups being treated with sodium oxybate achieved a 35% reduction in pain according to the pain VAS, while only 20% of patients on the placebo achieved such a reduction. These statistics are considered to be quite significant.
The FIQ gave equally promising data in that physical functioning for patients treated with the drug rather than the placebo was much improved, while there was a significant reduction in fatigue.