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  • BDD Moderators: Keif’ Richards

Anyone know why Lyrica didn't receive FDA approval for GAD?

D

DexyDevil

Bluelighter
Joined
Jul 20, 2012
Messages
186
I've only been able to find articles repeating the phrase "insufficient data." It seems a bit odd to me that SRRIs can make the FDA's cut for Generalized Anxiety Disorder but Lyrica can't. I find Lyrica to be the best anxiety treatment I have ever tried, and I've tried them all.
 
I did some Googling and found this:

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.
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Also, this: http://press.pfizer.com/press-release/pfizers-lyrica-receives-complete-response-letter-fda-generalized-anxiety-disorder-mono
 
DexyDevil said:
Hmmmm... Interesting. Pfizer apparently was "disappointed" by the FDA's decision. I still think that once Lyrica goes generic doctors will begin prescribing it like crazy for GAD. This will likely result in a lot of addiction and dependence and Lyrica's name will be tarnished a bit.
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Highly doubtful...

Lyrica still can’t hold anything close to opiate or benzo/barb withdrawal...

It just won’t touch you if you have any type of tolerance...

You literally have to douse grams of it with alcohol...
 
Psychedelic Jay said:
Highly doubtful...

Lyrica still can’t hold anything close to opiate or benzo/barb withdrawal...

It just won’t touch you if you have any type of tolerance...

You literally have to douse grams of it with alcohol...
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Maybe so, but I think his point was that the drug is addictive. Not that it is more addictive than others.
Gabapentin for example is quite addictive and from what I've read, VERY hard to get off.
 
Ugh i don't know about Lyrica but many doctors/psychiatrists prescribe gabapentin (supposively very similar to lyrica but slightly weaker) for anxiety, which didn't help me. I stopped taking it after being on it a year, i'm one of the lucky few that didn't have any MAJOR withdrawal symptoms.

But some many do say, that Lyrica does help them with anxiety especially ones in withdrawal, but as for why it didn't get approved idk.
 
Psychedelic Jay said:
Addictive is a very loose word... Jacking off is addictive...

Gabapentin and lyrica are not high strung drugs at all...
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There is an enormous amount of anecdotal support to indicate that Lyrica may be very habit forming. Abrupt discontinuation can induce seizure and many have described severe withdrawal syndrome.
 
Yeah the seizure thing is real true, lyrica and gabapentin both are also used as anti-seizure meds so that can happen from abrupt discontinuation especially.

But hey if Lyrica works for you then it works for you, that's good to know.
 
DexyDevil said:
There is an enormous amount of anecdotal support to indicate that Lyrica may be very habit forming. Abrupt discontinuation can induce seizure and many have described severe withdrawal syndrome.
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anecdotal= not necessarily true or reliable...

This mostly applies to people with previous drug habits. It is not meant to use withdraw off other substances.

Plus, if you use this with any other GABA drug, you are directly going directly along with exactly what you aren’t supposed to do with it.

Abrupt discontinuation only causes seizures to strengthen or re-appear that were already there.
 
Pregabalin carries the risk of addiction, dependance, and withdrawal (as seen in both anecdotes and studies). Also in one case study, status epilepticus was not present before withdrawal.

It's a relatively new drug. You're not going to find a ton of research behind its withdrawal and addiction as long as the largest pharmaceutical company in the world owns it. Besides, benzodiazepines have been around much longer (1960) and we still don't fully understand their withdrawal, and only in the last decade began to slightly grasp how to manage and treat these withdrawals.
 
Gabapentin is the best anxiolytic I have ever tried. It makes me so calm, happy and functional it's unbelievable. I would choose it over benzos or opiates for everyday use. I haven't tried Lyrica because my insurance won't cover it for GAD.
 
Marauder said:
Gabapentin is the best anxiolytic I have ever tried. It makes me so calm, happy and functional it's unbelievable. I would choose it over benzos or opiates for everyday use. I haven't tried Lyrica because my insurance won't cover it for GAD.
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It is definitely worth a switch if you can complain of neuropathy or just wait until it goes generic. Pregabalin is an amazing little chemical. Gabapentin has very poor bioavailability and isn't as smooth and effective as Pregabalin. I take 150mg 3x daily.
 
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