Schizophrenia.com

Effects of Roluperidone (MIN-101) on two dimensions of the negative symptoms factor score: Reduced emotional experience and reduced emotional expression

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Cant wait for this drug to come out seems its going to be exceptional.

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Anyone with access to the article: What were the adverse effects?

When is Roluperidone going to be available?

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If I remember well, a drug must go through 3 successive FDA-regulated phases before it can be approved, depending on the results of each phase.
This was phase 2b for Roluperidone. So maybe in two years, if everything goes well, it can start being commercialized.

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These are indeed phase 2b result as a stand-alone drug for both positive and negative symptoms.

However, it’s in phase III as add-on to antipsychotics and results are delayed I guess
(to the end of 2019) because it was expected in mid 2019. The timeline before it’ll pass as an add-on and can be commercialized in US/EU is indeed within 1/2 years.

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within 1/2 years: This is so great!

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That’s very encouraging. Glad to read some good news.

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Patients in the 32 mg/d group saw improvement in negative symptoms at 2 weeks, and both MIN-101 groups saw improvements at 8 weeks. Improvements were maintained throughout the trial. No notable improvement or worsening of positive symptoms occurred over the 12 weeks, and there was no significant change in body weight. Among those taking MIN-101 who reported adverse events (57.7% in the 32 mg/d group and 57.1% in the 64 mg/d group), headache (7.5%) and anxiety (6.8%) were the most common. Others included insomnia, schizophrenia symptoms, asthenia, and nausea.

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This drug doesn’t work on positive symptoms… big yikes, just another drug to feel happy

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This was tested as a monotherapy in place of a regular antipsychotic. The people involved were stable on an antipsychotic, and then switched to MIN-101 or placebo. Since the participants on MIN-101 instead of their regular med didn’t have any worsening of positive symptoms, it would appear that it does work for positive symptoms, at least as well as the other APs these folks were on.

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improvement in negative symptoms may be caused from stopping AP ?

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Can you find any information on a possible release date? I haven’t found anything exact

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If so, then why more improvement in the active group than the placebo group?

That’s why they have placebo control blinded trials.

There is a clinical trial (NCT03397134) underway scheduled to complete in March 2020. These almost never end on time. Apparently recruitment has been slow, and they are still recruiting so my guess is it will end sometime after March 2020.

They’ll spend some time analyzing the results and making an application to the FDA if the results were positive. The FDA will take 4 months to a year or so to approve or disapprove it, and then it usually takes awhile (months or more) to make it to pharmacies.

My guess is it could possibly be approved in 2021 if the phase 3 trial is a success - which we don’t know yet.

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