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.

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