Efficacy results: proven pain reduction with Hysingla ER dosed every 24 hours
Primary endpoint was met
- Patients treated with once-daily Hysingla ER achieved a statistically significant reduction in "average pain over the last 24 hours"* weekly mean score compared with placebo-treated patients at Week 12.1
The maximum treatment group separation was established by Week 4 and maintained through Week 12.1
Secondary endpoint: responder analysis
- Treatment with Hysingla ER resulted in a higher proportion of responders, defined as patients with at least a 30% and 50% improvement, as compared to placebo.
Responder Analysis: Percent improvement of patient's pain intensity from screening to Week 121*
Patients who did not complete the study were classified as non-responders.2
*“Average pain over the last 24 hours” was measured on an 11‑point Numeric Rating Scale (NRS) ranging from 0=“no pain” to 10=“pain as bad as you can imagine” during the double-blind period.