No one paid to have clinical trials in USA for sz, which costs a lot of money. The drug is generic now so I do not know if anyone would pay for USA trials. I also hope they would be liberal and approve it in USA based on foreign trials and safety.
2 Likes
Does anyone know if abilify lowers the prolactin levels on amisulpride, like it does for risperdone?
From what I have seen online a small dose of Abilify does reduce it
I believe there is a company persuing a version of amisulpiride in the US that is a new chemical entity - it would be under patent again in the new version. Which makes it more expensive but also pays for US trials. The new version was supposed to either be more effective or safer.
My google-fu is off today because I canât find it.
3 Likes
Jan. 22,2020 LB Pharmaceuticals, Inc., (âLBâ, or the âCompanyâ) announced today the administration of the first dose of LB-102 in a Phase 1 clinical trial. LB-102 is a novel benzamide designed to be an improved version of amisulpride, a drug successfully used in Europe but unavailable in the United States. The ongoing study aims to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of LB-102 in healthy volunteers.
LB-102 was designed to mimic amisulprideâs binding affinity to the D2/D3 and 5HT7 receptors while improving brain permeability.
2 Likes
I donât know why they cannot rely on international outcomes.
There must be so much data from people taking it already safely.
1 Like
I do not know if it is policy or law. I think they relied on German trials for Thalidomide that caused birth defects.
Thalidomide wasnât approved in the US til 1998 - thatâs not a typo. Itâs used for HIV wasting syndrome, some cancers, and graft versus host disease.
Just goes to show what weird drugs can get repurposed. But they are very careful not to use in pregnant women.