BREAKING NEWS: The U.S. FDA has rejected the proposed fibromyalgia drug sodium oxybate, saying it needs the manufacturer, Jazz Pharmaceuticals, to provide several things before the medication could be approved.
In the FDA's response letter to Jazz, the agency said it needs:
- Better patient population data from trials,
- Safety data,
- And a proposed Risk Evaluation and Mitigation Strategy (to show how it plans to keep the drug out of the wrong hands.)
Jazz released a statement saying the company plans to meet with the FDA to clarify the response letter before it evaluates the next steps for this drug.
The rejection shouldn't come as a shock to anyone -- back in August, an FDA advisory panel recommended against approval by a vote of 20 to 2. The FDA can go against this recommendation (as it did with Lyrica), but it rarely does. The panel's biggest concern was public safety, because sodium oxybate is chemically related GHB, the "date rape" drug.
Sodium oxybate is currently on the market as the narcolepsy drug Xyrem. To get Xyrem approved, Jazz had to put extremely stringent control measures in place. Even then, it was classified as an "orphan drug," meaning that it has a very limited usage. However, the fibromyalgia market is enormous when compared to the tiny narcolepsy market, so it's understandable that the FDA would be concerned about making a potentially dangerous drug more widely available.
This rejection isn't a flat out "no," but more of a "not right now." If Jazz can get the requested information to the FDA, it's possible that it would be approved. However, it could take years to compile those data and go through the approval process once again.
If it is approved, sodium oxybate may still be out of reach for many because:
- It's addictive,
- The safety screening and monitoring will exclude some people and be unattractive to others,
- It's an expensive drug -- to the tune of a couple thousand dollars a month.
Do you think we'll ever see this drug approved for fibromyalgia? Have you taken it, or have you tried to get it and been denied? Leave your comments below!
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