Additional clinical data from pivotal trial
Data from the randomized safety population (N=588) is shown below at different stages of the pivotal trial, including start doses vs end doses of Hysingla ER in the open-label dose-titration period; supplemental IR analgesic use in the double-blind period; the etiologies of chronic lower back pain, and analgesic use prior to study enrollment.
Open-label period: start doses vs end doses1,2
Of the patients randomized to the double-blind treatment period, most (90%) initiated therapy on Hysingla ER 20 mg once daily. However, at the end of the open-label dose-titration period, most patients had titrated to higher dosage strengths.
Open-label period: supplemental IR analgesic for breakthrough pain
- Patients were permitted to take up to 2 tablets per day of 5 mg immediate-release (IR) oxycodone (maximum of 10 mg per day), as needed for their lower back pain, with a minimum dosing interval of 4 to 6 hours
Double-blind period: supplemental IR analgesic for breakthrough pain
- Patients were allowed optional use of up to 6 tablets per day of 5 mg immediate-release (IR) oxycodone (maximum 30 mg per day), depending on their randomized Hysingla ER dose
| For patients randomized to once-daily Hysingla ER at the dosage strengths below: | Optional supplemental IR oxycodone 5 mg daily was allowed at the doses below: |
|---|---|
| 20 mg | Up to 10 mg (2 tablets) |
| 40 mg | Up to 10 mg (2 tablets) |
| 60 mg | Up to 15 mg (3 tablets) |
| 80 mg | Up to 20 mg (4 tablets) |
| 120 mg | Up to 30 mg (6 tablets) |
Percentage of patients who used optional supplemental IR analgesic during double-blind treatment period:
- 78% in Hysingla ER group; 83% in placebo group
Among patients who did use supplemental analgesic, average amount of IR oxycodone 5 mg used was approximately:
- 0.7 tablets per day in Hysingla ER group; 0.9 tablets per day in placebo group
Randomized population: etiologies of chronic lower back pain
| # of Patients | ||
|---|---|---|
| MedDRA-Preferred Term (≥1%) | n | (%) |
| Back pain | 500 | (85) |
| Intervertebral disc disorder | 33 | (6) |
| Spinal osteoarthritis | 23 | (4) |
| Intervertebral disc protrusion | 14 | (2) |
| Intervertebral disc degeneration | 10 | (2) |
| Spondylitis | 3 | (1) |
MedDRA = Medical Dictionary for Regulatory Activities.
Randomized population: medications used prior to study enrollment
| # of Patients | ||
|---|---|---|
| Prior Opioids (≥3%) | n | (%) |
| Hydrocodone/APAP | 163 | (28) |
| Oxycodone/APAP | 43 | (7) |
| Tramadol | 42 | (7) |
| Oxycodone | 26 | (4) |
| Morphine | 17 | (3) |
Prior non-opioids used: randomized safety population
- The most frequently used prior non-opioid medications (≥5%) were ibuprofen (40%), naproxen (19%), acetaminophen (18%), and cyclobenzaprine (6%)
