4 ms·
Good question, first thing to note is for FDA approvals adult is generally defined as 17 years of age. For the lack of pediatric indication, it's almost certai
by haldujai 3y ago
Good question, first thing to note is for FDA approvals adult is generally defined as 17 years of age.
For the lack of pediatric indication, it's almost certainly because the clinical trials used 18-45 as the inclusion criteria. This is typically done as it is (expectedly) easier to get Institutional Review Board ethics approvals for adults and considerably easier to recruit patients both simply because it's easier to recruit adults as well as the relative prevalence of adult PPD patients.
I'm not a psychiatrist but the similar intravenous drug this is based on (brexanolone) is approved at ages 15 and over so I don't expect there is any reason this would be ineffective.