HTX-011 significantly reduced opioid use for 72 hours after bunionectomy of the first metatarsal
According to recently published results, HTX-011 significantly reduced postoperative pain through 72 hours after a primary unilateral, distal, first metatarsal bunionectomy and significantly reduced opioid use. In addition, the treatment had a higher proportion of opioid-free patients compared with saline placebo and bupivacaine hydrochloride groups.
In EPOCH I, a randomized, double-blind placebo-controlled and active-controlled phase 3 trial, researchers assigned 412 patients who underwent a primary unilateral, distal, first metatarsal bunionectomy to receive a single dose of HTX-011 (bupivacaine and meloxicam in Biochronomer [AP Pharma] polymer technology), immediate-release bupivacaine hydrochloride (HCI) or saline placebo. Assessments were completed after 72 hours and patients were discharged. Follow-up assessments were performed at day 10, 28 and 42. Patients kept a daily diary and recorded whether they took opioids.
The mean area under the curve of the numeric rating scale (NRS) of pain intensity scores through 72 hours (AUC0-72) for the HTX-011 vs. the saline placebo group was the primary endpoint. Other endpoints included the AUC0-72 of the NRS pain intensity scores for HTX-011 vs. the bupivacaine HCl group, mean total postoperative opioid consumption through 72 hours for HX-011 vs. bupivacaine HCI and saline placebo groups and the proportion of patients who were opioid free through 72 hours for HTX-011 compared with bupivacaine HCl.
HTX-011 showed statistically significant results and a clinically relevant benefit for the primary endpoint and secondary endpoints. Investigators noted through 72 hours, HTX-011 showed superior and sustained pain reduction and significantly decreased opioid consumption. HTX-011 also resulted in significantly more opioid-free patients vs. the saline placebo and bupivacaine HCI groups.
All treatment groups had similar safety results. There were fewer opioid-related adverse events in patients who received HTX-011. – by Monica Jaramillo
Disclosures: Viscusi reports he receives research grants from Pacira and Durect; and receives consulting fees from AcelRx, Avenue, Cara, Concentric, Heron Therapeutics, Innacoll, Mallinckrodt, Merck, Neumentum, Pacira, Pfizer, Recro, Salix and Trevena. Please see the full study for a list of all other authors’ relevant financial disclosures.