Re: esketamina J&J

To nie wyglada tak prosto z esketamina. Niezaleznie od drogi podania sa dosyc powazne efekty uboczne. Sznase sa duze ale podjerzewam ze jesli FDA da zgode to beda musieli zrobic kolejne badanie Ph III i byc moze juz teraz bedzie wymagany jakis Black Box.
FDA Advisory Panel Will Consider Esketamine On February 12.
Bloomberg News (2/8, Flanagan) reports an FDA advisory panel will consider Johnson & Johnson’s “nasal spray, esketamine, a close cousin of the party drug ketamine,” on February 12. In a report, agency staff “raised questions about safety issues connected to a dreamlike sensation the medication can create in some users.” The report stated that it “takes roughly 90 minutes for disassociation symptoms from esketamine to resolve.” FDA personnel “also cited elevated blood pressure as a safety concern.”
        Endpoints News (2/8, Carroll) reports that in an internal review, regulators questioned an expert committee about whether “the FDA ignore its gold standard and approve...esketamine without solid supporting evidence from two well-controlled studies.” According to the regulators, this would come “after it failed in other studies and” while it “presents some serious safety issues.”