This! Looks like it could be a great step forward in treating psychosis!!
How far away from submission ?
From the article
No undesirable side effects were observed in Phase I human trials with a single dose of 18 mg tested.
So it’s in Phase 1 at least.
Sounds interesting.
Not only is it good for cognition but after reading the article I think it’s also an antipsychotic.
I’m not sure why they don’t fast track our types of meds like they would for cancer or ALS.
Getting us help just doesn’t seem to be a priority
Meghilla Gorilla I agree with you!
Getting schizophrenia(and all other diseases!) cured should be a top priority for society.
Technology is progressing which is good, but a, it needs to progress much more quickly b,
not enough emphasis is put on curing diseases, and specifically schizophrenia.
change is coming too slowly. We want and need rapid change for all of us!
All these mental health groups in existence,
All the support groups, all of the organizations and pharmeutical companies and they are YET to deliver us a better testament. Meanwhile last night I had a horrible bout of akithisia which was so uncomfortable and so heinous that I swore I would never take my atypical again. Now today I’m visibly shaken and unnerved from the experience. Atypicals are toxic
I saw something that it was in Phase 1 trial in 2010.
An article on phase 2:
AVN-322 phase 2, (2015)
That’s insane! It’s been six years and they’re just now starting phase two? This drug must be something special then, but hey no rush, there’s just 6 million people with psychosis trapped in their homes, in hospitals, contemplating suicide because of the tormenting voices and delusions.
I bet they held off to see what the other drug companies were pushing at the time and maybe decided that the world of psychiatry just isn’t ready yet for a breakthrough treatment. They’re (doctors, nurses, clinics, and professionals ) having too much fun playing house with a bunch of schizophrenics so they can pet themselves on the back at the end of the day and say "see were helping"
I would be suprised if they already have stuff that they know will change our lives but someone’s sitting on it waiting for the right time to make a buck.
■■■■ this system, ■■■■ the FDA.
Avineuro LLC announced completion of phase II pilot clinical study of AVN-211, a proprietary orally-bioavailable molecule of a 5-HT6 receptor antagonist. In a multicenter double-blind randomized placebo-controlled pilot study of efficacy and safety of AVN-211 for amplifying the effects of antipsychotic drugs in patients with schizophrenia in a condition of incomplete remission receiving stable antipsychotic therapy, 80 patients were randomized to receive 8 mg of AVN-211 or Placebo QD for 6 weeks (initial dose 4 mg of AVN-211 was prescribed QD for 1 week following dose ascending up to 8 mg QD for 5 weeks or equivalent Placebo). The drug was safe and well-tolerated, no serious adverse effects were reported. Although there were no statistically significant difference between the groups in primary efficacy endpoint, patients on atypical antipsychotics demonstrated the tendency of superiority over Placebo in mean reduction of PANSS General score and Positive scale score. These results support the assumption of AVN-211 mode of action and synergetic antipsychotic effect of 5-HT6 inhibitors in patients receiving atypical antipsychotics. Thus it has been suggested that AVN-211 should be further investigated specifically in larger population of schizophrenic patients in incomplete remission receiving stable antipsychotic therapy with atypical antipsychotics for demonstrating amplification of the antipsychotic effect.
So it’s an add-on that enhances an existing AP.
We’re talking about two different drugs now.
The original drug was AV-328 or something and it was in phase 1.
Yes, the link @robertc posted, pointed to that drug instead. Looks like a different drug. The only phase 2 I can find for the original drug is for Alzheimer’s.
The original drug AV-322 which is Ion the top of this thread is only in phase one maybe about to go to phase two. Just like the other drug AV 2(whatever)
They both started bent tested as long as 6 years ago.
That doesn’t seem like a lot of time when they say drugs take 15 years to make it through trials.
I was hoping that they would speed up the trials on meds sometime in the near future
Abstract:
Background: In recent years, 5-hydroxytryptamine subtype 6 receptor (5-HT6 receptor, 5- HT6R) has emerged as a promising therapeutic target for the treatment of neuropathological disorders, including Alzheimer’s disease (AD) and schizophrenia. 5-HT6 receptors were hypothesized to be implicated in the processes of learning, memory, and cognition with 5-HT6R antagonists being effective in animal models of cognition and memory impairment. Several selective 5-HT6R ligands are currently undergoing clinical trials for treatment of AD.
Methods: We describe results of preclinical development of a novel and highly selective and potent 5- HT6R antagonist, AVN-322, as a clinical candidate for the treatment of AD to improve concurrent debilitation of memory and cognition in the AD patients, and schizophrenia as a substance with antipsychotic effect. In the manuscript, we present its in vitro and vivo efficacy, ADME, pharmacokinetics in animals and in humans, and toxicity.
Results: While having high binding affinity in medium picomolar range, the lead compound demonstrates substantially better selectivity index then the reference drug candidates currently being tested in clinical studies. AVN-322 showed high oral bioavailability and favorable blood-brain barrier (BBB) penetration. In vivo testing revealed its clear cognition enhancing effect. AVN-322 significantly restored both scopolamine- and MK-801-induced cognitive dysfunction and demonstrated antipsychotic potential.
Conclusion: Taking into account its good safety profile and favorable pharmacokinetics, AVN-322 can be reasonably considered as a novel drug candidate for the treatment of neurological disorders such as AD and/or schizophrenia.
http://www.ingentaconnect.com/contentone/ben/car/2017/00000014/00000003/art00004
The drug companies are under such liability pressures that they need to be extra careful about the psychoactive drugs they bring to market. There are a lot of lawyers out there looking for class action law suits.
It’s for both, I wonder, will it be approved for AD I or schizophrenia first? I have no qualms with taking a medication like this for sza Even if it is off label.
I think the best bet for us is the drug Evenamide which is an add on but supposed to work very well with none of the usual side effects.
That and of course our old friend 007. And Min 101
Yea your right. Safety comes first. But a fifteen year gap from research to actual use is an extremely long time to wait.
You’re right. I, for one, am willing to take some risk to get the benefit of this med. They need to consider the detrimental effects of delaying for years its availability to the public.