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.
- Learn More: Ampligen for ME/CFS
UPDATE, NOV. 27, 2013 - The FDA rejected Ampligen, but the manufacturer said it wasn't done fighting.
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.
UPDATE, NOV. 27, 2013 - An FDA advisory committee is set to review the application in January 2014.
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.
UPDATE, NOV. 27, 2013 - Cymbalta's patent protection expires in December 2013. No word yet on when the generic form will actually hit the market. However, Lyrica's manufacturer won its battle to have patent protection extended through 2018, so we've got a long wait for generic pregabalin.
Photo © Seth Joel/Getty Images