Heron Therapeutics Establishes Synergy of Bupivacaine and Meloxicam with HTX-011 for Prevention of Post-Operative Pain in Phase 2 Clinical Studies
- Statistically significant synergy demonstrated with unique proprietary combination of bupivacaine and meloxicam in HTX-011 -
- Conference call and webcast at
HTX-011 is the first long-acting anesthetic developed to address both post-operative pain and accompanying inflammation by combining bupivacaine and meloxicam in a single administration. Utilizing Heron’s Biochronomer® sustained-release drug delivery technology, HTX-011 has demonstrated a statistically significant benefit over each individual component alone, providing evidence for the synergistic activity of bupivacaine and meloxicam in the HTX-011 formulation. Further data from Study 208 demonstrates that a 60 mg dose of HTX-011 produced a statistically significant reduction in both pain and opioid use compared to a 50 mg dose of bupivacaine solution, further supporting the synergy observed with the two components of HTX-011. In addition to these clinical data, Heron also announced preclinical data from a validated animal model demonstrating that the activity of bupivacaine and meloxicam in HTX-011 cannot be replicated by administering bupivacaine locally along with systemic administration of meloxicam.
“We are very excited to have confirmed the synergy between bupivacaine
and meloxicam when co-administered in HTX-011, which was previously
demonstrated in animal models,” said Barry D. Quart, Pharm.D., Chief
Executive Officer of
Study 208 is a randomized, placebo-and active-controlled, double-blind Phase 2 clinical study in patients undergoing bunionectomy. HTX- 011 demonstrated statistically significant superiority in post-operative pain management when compared to treatment with similar doses of bupivacaine solution, bupivacaine alone in the Biochronomer® polymer and meloxicam alone in the Biochronomer® polymer.
Conference Call and Webcast
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer® drug delivery
technology, is an investigational, long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam for the prevention of post-operative pain.
By delivering sustained levels of both a potent anesthetic and an
anti-inflammatory agent directly to the site of tissue injury, HTX-011
was designed to deliver superior pain relief while potentially reducing
the need for systemically administered pain medications such as opioids,
which carry the risk of harmful side effects, abuse and addiction.
HTX-011 is the subject of a broad-based Phase 2 development program
designed to target the many patients undergoing a wide range of
surgeries who experience significant post-operative pain. Following a
planned End of Phase 2 meeting with the
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially, including, but not limited to, those
associated with: whether the Phase 2 study results are indicative of the
results in future studies related to HTX-011, the sufficiency of the
Phase 2 data to allow the commencement of Phase 3 registration studies
for HTX-011, the potential market opportunity for HTX-011, the timing of
initiating Phase 3 studies for HTX-011, the timing of filing a New Drug
Application for HTX-011, and other risks and uncertainties identified in
the Company's filings with the
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior VP, General Counsel, Business Development and Corporate Secretary