NEWSBRIEF: Jazz Pharmaceuticals, Inc. says it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate) as a fibromyalgia treatment.
Sodium oxybate is the active ingredient in the drug Xyrem, which currently is on the market for narcolepsy. Many people take it off label for fibromyalgia.
Jazz says the application includes results from two Phase III clinical trials showing the drug significantly decreased pain and fatigue, and improved both daily function and sleep quality.
- Learn more about JZP-6 (Sodium Oxybate)
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i’ve been using sodium oxybate for 3.5 years and have noticed a great improvement in my life and recovery from fibromyalgia. i no longer have such disturbed sleep nor do i wake up stiff. a wonderful and positive change. i now can drive, take yoga, pilates, and weight training. i am so grateful to the people of jazz pharmaceuticals. i had been ill for many years, 28, and mostly bedridden the last 6. my sleep specialist, dr. bradley schnierow, has been overseeing my recovery with xyrem and sleep apnea mask and machine. he has helped me achieve my goal of visiting my grandchildren who live on the east coast. now i am hoping to make the big trip to israel to see my other grandchildren, whom i dearly love.
Xyrem is a trade name for gamma-hydroxybutyric acid or GHB, an endogenous neurochemical involved in regulating metabolism, especially regarding sleep or hibernation. In medical contexts GHB is often called sodium oxybate, which is an alternate term for the sodium salt of the chemical.
Xyrem does have many positive aspects, but as is always the case with any drug it may not be right for everyone. Make sure you talk with your doctor if you take other drugs that also make you sleepy or drowsy or if you experience any of the following conditions:
If you have any of the conditions below, you may need a dose adjustment or special tests to safely take this medication:
* liver disease;
*heart disease, high blood pressure, or kidney disease;
*a history of alcohol or drug abuse;
*a lung disorder such as asthma, emphysema, or bronchitis;
*sleep apnea (breathing stops during sleep);
*depression or suicidal thoughts; or
*mental illness such as bipolar disorder or schizophrenia.
Per Drugs.com