This is in phase 3, if it continues to perform well in the trials, it’ll be out in a few years. What struck me was that in this trial (link below) 46% of the patients in one of the dosage groups met remission criteria during the 4 week study.
Side effects? Probably, because it acts on a wide array of receptors, however there are some postive indications:
“On the safety front, 4 weeks of RP5063 resulted in no differences compared with placebo in terms of body weight, lipids, or blood glucose, suggesting the drug may produce fewer of the metabolic problems common of current atypical antipsychotics, noted Dr. Cantillon. Also, there were no significant differences between active treatment and control patients in terms of movement side effects or ECG changes. Serum prolactin levels declined by nearly 50% in all RP5063 treatment arms”
It’s primarily for positive symptoms, but mouse models suggest it might help cognition. It’s being tested in acute schizophrenia though so the primary goal of the trials is a reduction in the PANSS. If it does help cognition, that’d be a great side benefit, but it’s not a primary target for the study.
That’s probably why people aren’t very excited about it yet. If it proves beneficial for cognition or negatives in the late clinical trials, tables might turn.
I think that the anti psychotic you talk about RP 5063 is considered very safe.
If it even takes care just of positive symptoms but without side effects that’s already good.
That said, I think the focus should be cognition and negative symptoms.
@Andrey I realize this board has pretty high functioning people, meaning mostly responsive to meds, but I know there are some with a less than sufficient response, or who just say ■■■ meds, because they don’t do enough to be worth the side effects. So this could be really helpful.
@Erez_Shmerling it is a serious concern and I know they’re working on it, but there are a lot of unmet needs. They’re not saying this will be side effect free, but if it doesn’t make you grow boobs, make you fat, hurt your heart, or cause movement disorders, it will be a big step forward.
Where does it say it’s moved to phase III? On the Reviva site it says it’s in preparation for phase III. Wonder why they didn’t move to phase III already since the phase II trials already ended in 2013 with positive result… Sucks!
It is frustrating. Yeah I don’t think they are actually recruiting yet but they literally just (last month) raised like $12 million to fund their upcoming trials and research. This one is a big one for them, it may have dual use, also for pulmonary hypertension.
It’s in a holding pattern waiting for results from the bipolar and other studies. In the phase 2 and 3 studies it consistently had an improvement on the PANSS of around 13, 14 points. But the placebo effect went from 7 points in one trial to 10 in another to 15 in the last trial. That the drug effect was fairly consistent, even though the placebo effect wasn’t consistent, is probably a good sign that it may work. The FDA is still willing to consider it, because high placebo rates have been a major problem with many psych drug studies, but Intracellular will still have to prove it works (and is safe) They have said they will be submitting an application for approval in mid-2018.
Oh I dug deeper on the side effects reported on RP5063 in the phase 2. The only things that really stood out were akathisia (up to 10% of participants at the highest dose) and insomnia, around 25% experienced that. So that’s an important side effect, but if it can be countered with a sleeping med, not so bad. Also, another way to look at it, 75% of the people didn’t get insomnia and 90+% did not get akathisia.
Amused though, they have to report everything, literally. Someone got a spider bite, and another person got a scratch, and that’s listed in the study results.
That just means they’re not recruiting yet. Or if they are, it’s not through clinicaltrials.gov, but they could be developing contacts through hospitals. Or they may just be, as they say “in preparation.” I agree, it’s taking a really long time, but they wouldn’t have gotten 12 million in financing if they weren’t going to pursue it.