I didn’t want yahoo in my browser cookies so here it is as Bing AI:
Reviva Pharmaceuticals has announced positive topline results from its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety, and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia12.
The trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-23.9 brilaroxazine 50 mg vs. -13.8 placebo, p<0.001) at week 412.
Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo12. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints12.
The drug was generally well-tolerated with a side effect profile comparable to placebo for the 15 and 50 mg doses of brilaroxazine; discontinuation rates for brilaroxazine were lower than placebo12.
Topline data from a 1-year open-label extension (OLE) trial is expected in Q4 202412.
This is the company’s press release: Company press release
PANSS reduction of 23.9 is excellent, side effects were good.
Why would this drug has less side effects than other similar drugs?
I think this is the first drug to have a very high affinity for the D4 receptor acting as a partial agonist.
Good question.
Brilaroxazine, also known as RP5063, is an investigational atypical antipsychotic which is under development by Reviva Pharmaceuticals1. It’s described as a “dopamine-serotonin system stabilizer” due to its unique actions on dopamine and serotonin neurotransmitter systems1.
While it’s difficult to say which antipsychotic it’s most similar to without more detailed information, it does share some similarities with aripiprazole (Abilify) in terms of its actions on the dopamine and serotonin systems1. However, each antipsychotic has a unique profile and can affect individuals differently. It’s important to note that while these drugs may have similar mechanisms of action, their efficacy and side effect profiles can vary significantly12.
is bing ai’s answer.
Dam, I am on Abilify/Amisulpride currently. If I had access to this medication, my gut tells me that I would be just taking that one. I am sure it would have worked, since Abilify is pretty potent for me. Is this medication stronger than Abilify? And, does it cause TD in the long-run?
I have no idea. sorry
This is interesting:
““The consistent response across all primary and secondary endpoints at the 50 mg dose and improvement in all major domains, including, negative symptoms and personal and social performance is strong support for brilaroxazine’s robust activity. Moreover, the low placebo response is indicative of a well-run trial employing quality sites and investigators. This broad efficacy profile coupled with low discontinuation rates and favorable tolerability supports the potential of brilaroxazine to address limitations of standards of care and potentially be a long-term treatment option for this chronic and complex disease.””
Though I am not sure what social cognition means, this medicine is also good for negative symptoms
I read the medication will not be available before 2025.
Here is more form the website:
" Key clinical safety and tolerability findings of brilaroxazine support a well-tolerated safety profile:
- No drug related serious adverse events (SAEs) or treatment-emergent SAEs (TESAEs) observed or major safety concerns reported for brilaroxazine after 4 weeks of treatment
- No incidence of suicidal ideation
- No significant change in bodyweight, blood glucose levels, lipids levels, or endocrine hormones (prolactin, thyroid hormone) compared to placebo
- Akathisia and extrapyramidal symptoms <1% reported for brilaroxazine 50 mg and none for 15 mg
- Low discontinuation rates with brilaroxazine that were less than placebo (16% in brilaroxazine 50mg and 19% in brilaroxazine 15mg vs. 22% placebo)"
There is weight gain in the medication!!!
"Patients on placebo had a score of -13.8, which Reviva said was a “clinically meaningful” 10.1-point reduction.
The study also showed that 5.9% of patients who were administered brilaroxazine gained weight as a side-effect, while 2.9% of patients on placebo faced the issue, Reviva said.
The weight gain in the treatment group is “not reflective of a long-term outcome,” CEO Laxminarayan Bhat said on a conference call with analysts."
Reviva Pharma’s schizophrenia drug succeeds in late-stage study | Reuters
Lol they always say not reflective, its the same mode of mechanism, what do you expect?
Each different molecule produces different metabolites in the body that act in different ways.
5.9% is a small percent.
regarding the picture.is this means the drug have adverse effect on lungs or it has protective effect?
is these effects common in other antipsychotics specially lurasidone?
This drug is protective.