Heron Therapeutics Announces Positive Topline Results From Phase 2 Clinical Trial of HTX-011 in Abdominoplasty
01/04/2017
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- HTX-011 produced statistically significant reductions in both pain intensity and need for opioids following abdominoplasty (tummy tuck) through 96 hours post-surgery -
- Results confirm broad utility of HTX-011 with successful use across wide range of surgeries, from small to very large incisions -
- Conference call and webcast at
Study 203 is a randomized, placebo-controlled, dose-finding, Phase 2 clinical study evaluating the efficacy and safety of locally administered HTX-011 for post-operative anesthesia following abdominoplasty surgery. The Summed Pain Intensity (SPI) score through 96 hours post-surgery (SPI 0-96) was significantly reduced with HTX-011 and produced a statistically significant 36.6 percent reduction in pain through 96 hours following surgery, as measured by SPI 0-96 (p=0.0104). Pain was consistently reduced through 96 hours with statistically significant reductions observed between 24 to 48 hours (p=0.007), 48 to 72 hours (p=0.038), and 72 to 96 hours (p=0.016) after a single administration of HTX-011.
Additionally, HTX-011 produced significant reductions (p=0.011) in the use of opioid rescue medication through 96 hours following abdominoplasty, as compared to placebo. To date, HTX-011 continues to be generally well-tolerated in Phase 2.
“The most painful period following surgery is the first three to four
days. Currently available local anesthetics do not have the duration of
action to provide analgesia for these critical first few days. Poorly
managed post-operative pain can result in impaired patient function,
increased cost of care and potentially lead to chronic pain and
long-term opioid use,” commented
“Today’s abdominoplasty results, combined with previously reported data
from our Phase 2 programs in bunionectomy and hernia repair, demonstrate
the potential for HTX-011 to provide broad utility and efficacy across
multiple surgery types, from the smallest to one of the largest surgical
incisions,” said Barry D. Quart, Pharm.D., Chief Executive Officer of
HTX-011 is the first long-acting anesthetic that is designed to address both post-operative pain and accompanying inflammation by combining the local anesthetic bupivacaine and the anti-inflammatory meloxicam in a single administration. Targeting both pain and inflammation has allowed HTX-011 to demonstrate an advantage over current standard of care in multiple surgical models in Phase 2 studies.
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
About
Forward-Looking Statements
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
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Source:
Investor Relations and Media Contact:
Heron Therapeutics,
Inc.
David Szekeres, 858-251-4447
Senior VP, General Counsel,
Business Development and Corporate Secretary
dszekeres@herontx.com