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2013 drug outlook for Fibromyalgia and Chronic Fatigue Syndrome
Sunday 13 January 2013
Will we see new drugs for either fibromyalgia (FMS) and chronic fatigue syndrome (ME/CFS) in 2013? It's possible we'll see the first-ever drug approved for ME/CFS, as well as an off-label treatment for both conditions.
Ampligen for ME/CFS
Ampligen (rintatolimod) is right now before the FDA as a treatment for ME/CFS, with a decision due by February 2. An advisory panel recommended against approval, but the FDA isn't bound by that recommendation. It usually agrees with the panel, but the fact that ME/CFS currently has no approved medications, combined with political pressure from the White House and the NIH, could sway things in Ampligen's favor.
Northera: Off-Label for FMS & ME/CFS
The drug Northera (droxidopa) continues to wend its way through the complex regulatory process as well. Last spring, the FDA sent it back to the manufacturer for more trials and specific data. The company has said it's pushing forward in its attempt to bring this drug to the market. Early trials show that Northera may be effective as an FMS or ME/CFS treatment, but the approval would be for neurogenic orthostatic hypotension (NOH,) meaning a blood-pressure drop upon standing that causes dizziness or fainting. NOH is a symptom of these conditions, so if it is approved, some doctors may be willing to prescribe it for us.
Northera is designed to boost your brain levels of norepinephrine, a neurotransmitter that plays an important role in FMS and ME/CFS. All three FDA-approved FMS drugs also impact norepinephrine levels.
Mixed News: Generics
This year, we'll see patent protection expire for two FMS drugs, Lyrica (pregabalin) and Cymbalta (duloxetine.) Cymbalta's runs out in June, and the FDA all ready has approved generic forms - which will likely be far less expensive. That'll mean a financial break for those shelling out big bucks for the drug, and a new option for those who couldn't afford it.
Lyrica may be a different story, though. Its original patent will expire in October, but a later patent that's being upheld by the courts is in effect until December 2018. That means we probably won't see generic forms of pregabalin for another six years.
The above, with comments, originally appeared here.
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