Horizant

[Manicsleep]

Well we had a lot of interesting talk (still continuing) about NueDexta so I wanted to bring up a drug that I have been following.

I am a bit wary of the FDA's approval of Horizant. It is a prodrug of gabapentin that supposedly has a better absorption than gabapentin by itself.
The indication so far is only moderate to severe RLS I think. I am not sure if it will be used to treat epilepsy, pain, AIDs or climate change.

Personally, I hope there are less abuse issues with this garbage than there were/are with Neurontin. It will be interesting to see the fallout.

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[whopper]

Whenever companies come out with a new medication that is, for all intents and purposes, basically the same as the old drug with only one new twist, I rarely find the newer drug to be superior to the older with most patients, while the newer one commands a very high price.

e.g. Lexapro vs. Citalopram, Lyrica vs. Neurontin, Pristiq v. Effexor XR.

I have, on occasion, noticed some difference in some patients, but it was the overwhelming minority.

 

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[Manicsleep]

The claim is that its for RLS, so far, but it also failed FDA approval last year because of increased risk of cancer. Sounds a little fishy but pharma companies have a habit of getting their way. If a problem arises later, they can just blame the physicians.

Also, when these medications are approved, I wonder if the FDA looks at whether they actually offer any real benefit over existing medications, such as requip or even gabapentin. RLS is usually treated fairly well with low dose gabapentin. I am sure none of the drug reps will mention the workup that is needed to rule out underlying causes.

In my experience, RLS is often 'cured' by addressing underlying nutritional deficiency.

 

[atsai3]

Also, when these medications are approved, I wonder if the FDA looks at whether they actually offer any real benefit over existing medications, such as requip or even gabapentin. RLS is usually treated fairly well with low dose gabapentin. I am sure none of the drug reps will mention the workup that is needed to rule out underlying causes.

Drug companies are not required to submit trials that compare new drugs to the standard of care. All the FDA needs to act are 2 placebo-controlled trials. (Sometimes the FDA will award an indication with even less information, eg., BMS received FDA approval for the use of aripiprazole in bipolar maintenance with just 1 [lousy] trial. That being said, I am not clear as to what determines when a drug company needs 2 studies vs just 1 study.)