Valbenazine approved for tardive dyskinesia

[SomeDoc]

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A reversible VMAT2 inhibitor that helps reduce tardive dyskinesias was approved by the FDA today. It's nice to see this as an option in managing psychotic signs and symptoms where higher than average doses of neuroleptics are indicated, as TDs can at times be quite debilitating.

FDA approves first drug to treat tardive dyskinesia

 

[AnnoyedByFreud]

I'm excited to see this approved - I was just at a conference where they were discussing this as an upcoming med. The research was quite impressive, though industry funded. But if it's even half as efficacious/tolerable as they purport it will be a huge win. Unfortunately, I worry that the patients who would most benefit from this med (people seen by county with chronic schizophrenia, on multiple neuroleptics) probably won't be able to afford it. Hopefully there will be a decent affordability program from the pharm company.

 

[masterofmonkeys]

Luckily the FDA's byzantine structure prevents Tetrabenazine (old and very generic basis for valbenazine) from being recognized as a tx for Tardive dyskinesia. It's been around since the 1950s but beause it only got orphan status in 2008, it is considered brand name.

In 2020, it should be dirt cheap though.

 

[AnnoyedByFreud]

If it's like tetrabenazibe you'll have pts become catastrophically depressed or suicidal as might be expected if you deplete someone's catecholamine stores

This was discussed at the talk I attended. If I remember correctly, I believe this med is an enantiomer of tetrabenazine and supposedly has far fewer side effects, is selective for vmat2 and dopamine only - no other monoamines, no increase in depression/suicide during the trials, etc. How this will play out will be interesting, since once again the trials were industry funded. The speaker said it had "virtually no side effects" during the trials and was sped up by the FDA to be approved.

 

[Ahamis]

I just heard in a lecture today that the treatment with this new drug will cost 50k/ year.
I would like to hear if any of you are successful in getting insurance prior authorization.

 

[birchswing]

I am surprised at how many times I have been told a drug has no or virtually no side effects—it immediately makes me suspicious. The most surprising was when I was suggested to take low dose stelazine, told at low doses there were no side effects, and the doctor challenged me to find evidence of any side effects at the low doses she was suggesting (she said she was sure the only side effects I'd be able to find were at normal doses). It was actually very easy to find side effects listed for even low doses (and at that irreversible scary side effects). To this date the only drug I have seen with virtually no side effects is simethicone, but I think I mentioned that once before here and someone pointed out there was some. When people say no side effects, I assume they are either confused or are trying to do an end-round around my hyper-vigilance, which is pretty much the worst way to do it. It's like telling someone afraid of swimming there's no water in a swimming pool when it's right there.

 

[thoffen]

I wonder about the duration of the trials. You can make someone's TD better by upping their antipsychotic dose.

Which is a lot like this wonder drug Xanax. Really effective for treating anxiety. Amazing trial results and no one seems to experience treatment limiting side effects! Incredible that anxiety disorders still exist.

Ok back to reality. With antipsychotics you end up pumping out more dopamine after a while which just makes the problem worse. Does that happen with a VMAT inhibitor?

 

[philosophize]

Neurocrine Biosciences (NBIX) who is making valbenzaine has an estimated value at 4.6 billion dollars ..... time to short, eh?

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