Proven efficacy in the pivotal trial and evaluation of safety in patients treated with Hysingla ER
Pivotal trial
The pivotal trial was a randomized, double-blind, placebo-controlled, multicenter, 12-week study that evaluated the analgesic efficacy and safety of once-daily dose Hysingla ER tablets compared with placebo in opioid-naïve and opioid-experienced patients with moderate to severe chronic lower back pain.1,2
The primary efficacy assessment was the mean weekly pain intensity, calculated using patients' daily diary "average pain over the last 24 hours" at Week 12. "Average pain over the last 24 hours" was measured on an 11-point numeric rating scale ranging from 0="no pain" to 10="pain as bad as you can imagine."1,2
Additional data from the pivotal trial show details about the range of starting doses, titration, use of supplemental analgesia, sources of back pain, and prior use of analgesics of patients who entered the study.1,2
Adverse reactions
The most common adverse reactions (≥5%) reported by patients treated with Hysingla ER in the chronic pain clinical trials were constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.2
