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Sodium Oxybate

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Category: Medical Info and Drug Trials

Published on Thursday, 09 July 2009 15:11

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Jazz Pharmaceuticals and UCB announced on 24th June 2009 that there have been positive preliminary  results from the second of two Phase III clinical trials of Sodium Oxybate (JZP-6) for treatment in Fibromyalgia.  In confirming the positive results from the first Phase III study this placebo-controlled trial of Sodium Oxybate has achieved its key claims in the treatment of Fibromyalgia. 

As well as in the first random, double-blind Fibromyalgia study, Sodium Oxybate showed to significantly decrease pain and fatigue and also improved general daily function and patients' all round sense of change.  Although Sodium Oxybate (brand name Xyrem) has not been approved or regulated by the American Food and Drug Administration (FDA) for the treatment of Fibromyalgia it has shown a positive affect on several symptoms of Fibromyalgia so therefore it could have a positive impact on patients' quality of life.

This second Phase III trial lasted for fourteen weeks and included 573 adult patients with Fibromyalgia. There were three different types of treatment:  Sodium Oxybate 4.5g per night; Sodium Oxybate 6.0g per night and a placebo.

The results showed a positive proportion of patients achieved a 30% or more reduction of pain, based on the Pain Visual Analog Scale (VAS), compared to 20% of patients given the placebo.  The results were deemed to be highly significant in that the improvement in fatigue and physical performance of those given the Sodium Oxybate were much greater than those given the placebo.  With regard to adverse effects, the most commonly reported were nausea, sickness, dizziness, insomnia, anxiety, drowsiness, fatigue, muscle spasms and fluid retention.  In general it was well tolerated with side effects reported as being mild to moderate.

In conclusion the positive results of both the two Phase III trials suggests that, subject to it being regulated, Sodium Oxybate may offer a new treatment option for patients with Fibromyalgia.  Further analysis is planned and Jazz Pharmaceuticals anticipates that by the end of 2009 they will have submitted a New Drug Application to the US Food and Drug Administration.