26 June 2018 - - Redwood City, California-based commercial-stage biotechnology company Heron Therapeutics, Inc. (NASDAQ: HRTX) has released positive topline results from two completed phase 2b studies of HTX-011 with the primary endpoints achieved in both, the company said.
Study 209 was a randomized, placebo- and active-controlled, double-blind, phase 2b clinical study in patients undergoing primary unilateral total knee arthroplasty to evaluate HTX-011 locally administered into the surgical site. The primary endpoint was pain intensity as measured by the area under the curve (AUC) from 0 to 48 hours post-surgery for HTX-011 compared to placebo.
The HTX-011 combination and HTX-011 alone resulted in reductions of 23% and 19%, respectively, in pain intensity measured at rest through 48 hours when compared to placebo.
Study 211 was a randomised, placebo- and active-controlled, double-blind, phase 2b dose-finding study in patients undergoing augmentation mammoplasty to evaluate HTX-011 when administered by instillation into the surgical site or via nerve block before surgery.
The primary endpoint was pain intensity as measured by the AUC from 0 to 24 hours post-surgery compared to placebo.
HTX-011 400 mg administered by instillation into the surgical site and HTX-011 400 mg administered as a nerve block both resulted in reductions of 22% in pain intensity measured at rest through 24 hours when compared to placebo.
HTX-011, which utilises Heron's proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX-011 was well tolerated in both studies, with a safety profile comparable to placebo and bupivacaine solution.
Heron Therapeutics is focused on developing best-in-class treatments that address unmet patient needs. The company is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain.