Safety results from pivotal trial: reported adverse reactions
Adverse reactions reported in >2% of patients during the open-label titration period and double-blind treatment period
10 patients had treatment-emergent nonfatal serious adverse events (SAEs)1
- 4 patients (7 events) in the open-label, run-in period
- 6 patients (10 events) in the double-blind period
- 4 patients in the placebo group; 2 patients in the Hysingla ER treatment group
None of the SAEs were considered as possibly, probably, or definitely related to study drug by the investigators.
Incidence of treatment-emergent adverse events that led to study drug discontinuation: 11% in open-label, run-in period and 4% in double-blind period (3% in placebo group; 4% in Hysingla ER group).