Are there any indications that Lyrica (Pregabalin) will gain FDA approval for the treatment of G.A.D?
Are there any indications that Lyrica (Pregabalin) will gain FDA approval for the treatment of generalized anxiety disorder in the near future? It is currently approved for the treatment of G.A.D in the European Union, but not in the U.S. where approval for on-label use has been granted for neuropathic pain and fibromyalia. The said approval has also been granted in South Africa (where I am from) as well. Treatment for G.A.D., however, is currently off-label. I ask because The Medicines Control Board of South Africa usually follows suite with F.D.A. guidelines (this has led to numerous criticism as regards the treatment of ADHD. - Both state (where treatment is free) and the private medical sector have been accused of handing out Ritalin as if it were candy. Personally I'm not too bothered whether E.U. or F.D.A. guidelines are followed. - Both are very adept, and South Africa does not have the resources to reinvent the wheel in regards the approval of medications and recommended treatments).
At any rate, if/when approved by the F.D.A for treatment of G.A.D., South Africa will (as mentioned) probably follow suite. - This would mean that I could get Lyrica added to my chronic benefits on medical aid (or medical insurance, as it is referred to in the U.S.) and that, should I motivate for state to provide it (which I am currently doing, although I don't expect my application to be granted. - It has been explained to me that the circumstances under which this drug will be provided for G.A.D. have to be very exceptional indeed).
Sorry for this rather verbose question, your response is much appreciated.
- Az RLv 69 years agoFavorite Answer
Some time ago, Pfizer, the manufacturer of Lyrica had submitted what we call an sNDA (supplemental new drug application) to the FDA. This is what a manufacturer uses when they have a drug that has been approved for one use, and they are able to sell, but they want the FDA to add an approval to the drug's label.
However, in January 2010, Pfizer withdrew this sNDA from the FDA. This came along with cuts to a large number of research projects and drug approvals Pfizer was working on. Since the company that makes the drug is no longer actively seeking to get it approved for this new indication, it is very unlikely that we're going to see the FDA approve Lyrica for GAD in the near future.
While Pfizer always has the option of resubmitting this request, this cut came as a result of the buying up Wyeth, a drug company that got itself eviscerated in a protracted legal battle with the generic drug maker Teva. Pfizer apparently found itself spread too thing to pursue all these projects and goals.
- AreaLv 44 years ago
I'm on lyrica but for sciatica (nerve pain) though suffer from mental health problems as well. The first day I took it I felt dizzy and had nausea. The second day I felt a bit better and after a week I was ok. I started on 75mg twice a day and when I upped it to 150mg twice daily I've been fine. If the side effects don't go away then speak to your doctor or pharmacist.