# Anyone in the know...is ALKS 5461 likely to get approved this year?



## devin44 (Nov 19, 2014)

We need something like this, stat!


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## devin44 (Nov 19, 2014)

Any ideas guys?


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## TDX (Jul 12, 2014)

If their current data is sufficient I'm confident that it might become available in this year or in 2018.


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## Hedgehog fuzz (Dec 12, 2016)

Why do we need this so urgently? If somebody could condense the reason, that would be great. thanks.


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## DPFighter (Apr 8, 2013)

TDX said:


> If their current data is sufficient I'm confident that it might become available in this year or in 2018.


Why do you feel so confident when 2/3 trials failed? It's been a while since you posted this. What are your feelings about ALKS 5461 at this point? Still confident it will be approved?


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## TDX (Jul 12, 2014)

> Why do you feel so confident when 2/3 trials failed?


You misunderstood this a bit. I said "if their current data is sufficient", meaning it is uncertain if their current data is sufficient at all. My estimation on the time for ALKS-5461 to gain approval was based on the best outcome, namely that their data was already sufficient.



> It's been a while since you posted this. What are your feelings about ALKS 5461 at this point? Still confident it will be approved?


I don't know enough about the whole process to make a reliable prognosis. However I know that there are drugs which supposedly performed worse in trials, but were still somehow approved. One example is the antidepressant Agomelatine.

Recently the company who made ALKS-5461 started a new clinical trial:
https://clinicaltrials.gov/ct2/show/NCT03188185?term=ALKS-5461&recrs=ab&rank=1

This clinical trial is a bit different to the others. It's most important difference is that they use instruments to assess emotional blunting and anhedonia. The new trial could mean, that the company believes that their current results won't be enough. Hence they want to prove in another one that their compound outperforms placebo and improves symptoms like anhedonia, for which current drugs are often less effective than against other depressive symptoms. A robust anti-anhedonic effect might increase their chances.

Sadly, if they also need this trial, we would have to wait much longer for ALKS-5451. The new trial is scheduled to end in november 2019. Then ALKS-5461 would reach the market at the end of 2020 or more likely in 2021.

It's very sad. When I first heard of it in 2014, I hoped for it to become available in 2016. But it seems like it may take even longer than that.

Even more sad is that this treatment seems to be already available. There is evidence that combining Buprenorphine with Naltrexone would work just as well. Both drugs are available since 1984, so blocking the kappa-opioid-receptors was principally possible for *30 years*. But the fucking psychiatrists were seemingly not interested.

But who knows... Maybe I can persuade mine next time to prescribe it.


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## DPFighter (Apr 8, 2013)

TDX said:


> You misunderstood this a bit. I said "if their current data is sufficient", meaning it is uncertain if their current data is sufficient at all. My estimation on the time for ALKS-5461 to gain approval was based on the best outcome, namely that their data was already sufficient.
> 
> I don't know enough about the whole process to make a reliable prognosis. However I know that there are drugs which supposedly performed worse in trials, but were still somehow approved. One example is the antidepressant Agomelatine.
> 
> ...


2021 is such a long wait I was hoping it would be next year. If you are going to try Naltrexone what is the purpose of even combing it with Buprenorphine? Isn't the Naltrexone good enough to try on its own?


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## TDX (Jul 12, 2014)

> If you are going to try Naltrexone what is the purpose of even combing it with Buprenorphine? Isn't the Naltrexone good enough to try on its own?


The purpose of the combination is to use Buprenorphine's kappa-opioid-antagonism, but without activating mu-opioid-receptors - this is prevented by Naltrexone. It would also be possible to block kappa-opioid-receptors with Naltrexone alone, but high doses are required to achieve this. Side-effects of Naltrexone probably can be unbearable on that dose for many people and there is an additional risk of liver damage. Another serious problem is the high price of Naltrexone. Unless you are rich, you cannot afford 250 mg/day for good.


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