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news.US-based biotechnology firm Heron Therapeutics has started a second Phase II clinical trial of HTX-011, which uses the company's Biochronomer drug delivery technology, for the treatment of post-operative pain.
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HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam.
Around 60 patients undergoing inguinal hernia repair will be included in the placebo-controlled, dose-finding Phase II trial, which will evaluate the efficacy and safety of HTX-011, containing 200mg or 400mg of bupivacaine combined with meloxicam, compared to placebo.
Currently, HTX-011 is also being evaluated in a placebo-controlled, dose-finding Phase II trial in patients undergoing bunionectomy.
The company noted that in a previously completed, placebo-controlled Phase I trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam, with therapeutically relevant plasma bupivacaine levels sustained for 2-3 days.
Heron chief executive officer Barry Quart said: "We are extremely pleased to be expanding our Phase II development program for HTX-011 with the initiation of a study in patients undergoing hernia repair.
"Our ongoing clinical trial in patients undergoing bunionectomy is progressing extremely well, supporting the expansion of the HTX-011 Phase 2 development program.
"We look forward to reporting data from both the bunionectomy study and the hernia repair study in the second half of 2015."
HTX-011 was designed to deliver superior pain relief as well as potentially reduce the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction.