SAN DIEGO, Jan. 3, 2019 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology
company focused on improving the lives of patients by developing
best-in-class treatments to address some of the most important
unmet patient needs, today announced results of a multi-center
postoperative pain management study in which 63 patients undergoing
hernia repair surgery received the investigational agent, HTX-011,
together with a regimen of generic over-the-counter (OTC) oral
analgesics (acetaminophen and ibuprofen). Designed as a follow-up
to the Phase 3 study in hernia repair completed in 2018, this study
included many of the same investigators and the same entry criteria
as the Phase 3 study. The goal of the current study was to increase
the proportion of opioid-free patients by combining HTX-011 with a
regimen of readily available, oral analgesics.
Topline results of the study include the following:
- 90% of patients receiving HTX-011 with the OTC analgesic
regimen did not require opioids to manage their postoperative pain
through 72 hours post-surgery, compared to 51%, 40% and 22% of
patients receiving HTX-011, bupivacaine and placebo, respectively,
in the prior Phase 3 study.
- 81% of patients receiving HTX-011 with the OTC analgesic
regimen remained opioid-free through 28 days post-surgery.
- Over 72 hours post-surgery, patients receiving HTX-011 plus the
OTC analgesic regimen consumed an average of 0.9 morphine milligram
equivalents (MME), which compares to 10.8 MME, 14.5 MME and 17.5
MME for patients receiving HTX-011, bupivacaine and placebo,
respectively, in the prior Phase 3 study.
"Overprescribing of opioids not only puts patients at risk of
persistent use, addiction or dependence, but also results in unused
pills available for potential misuse or abuse by others," said
Harold S. Minkowitz, M.D., Associate
Professor and Associate Director of Clinical Research at the
University of Texas MD Anderson Cancer
Center, Department of Anesthesiology and Perioperative Medicine.
"Recently, a U.S. Food and Drug Administration Advisory Committee
reported that, at time of discharge, patients receive an average of
30 opioid pills (range of 15-120 opioid pills) following open
hernia repair surgery, while only 9 of these opioid pills are used.
This suggests that, with a drug that substantially reduces the need
for postoperative opioids such as HTX-011, surgeons could eliminate
opioid prescriptions for almost all of their patients and in turn
significantly reduce excess opioid pills going out into
communities. For hernia repair alone, this would mean a reduction
of almost 30 million opioid pills every year."
"Reducing discharge prescriptions for opioids after surgery,
while providing appropriate pain management, remains a high
priority in the battle against the opioid epidemic," said Barry D.
Quart, Pharm.D., Chief Executive Officer of Heron. "The results
announced today show us that, with HTX-011 as the backbone of a
multimodal approach to pain management, patients experience less
pain and few need an opioid prescription when they are sent home
following outpatient surgery. We look forward to presenting these
results in more detail during the upcoming 37th Annual J.P. Morgan
Healthcare Conference on Monday, January 7,
2019, at 5:00 p.m. PST at the
Westin St. Francis hotel in San
Francisco, CA."
About HTX-011 for Postoperative Pain
HTX-011, which utilizes 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. By delivering sustained levels of both a potent anesthetic
and a local anti-inflammatory agent directly to the site of tissue
injury, HTX-011 was designed to deliver superior pain relief while
reducing the need for systemically administered pain medications
such as opioids, which carry the risk of harmful side effects,
abuse and addiction. HTX-011 has been shown to reduce pain
significantly better than placebo or bupivacaine alone in five
diverse surgical models: hernia repair, abdominoplasty,
bunionectomy, total knee arthroplasty and breast augmentation.
HTX-011 was granted Fast Track designation from the U.S. Food
and Drug Administration (FDA) in the fourth quarter of 2017 and
Breakthrough Therapy designation in the second quarter of 2018.
Heron submitted a New Drug Application (NDA) to
the FDA for HTX-011 in October of 2018 and received
Priority Review designation in December of 2018. The FDA set a
Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology
company focused on improving the lives of patients by developing
best-in-class treatments to address some of the most important
unmet patient needs. Heron 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.
For more information, visit www.herontx.com.
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 FDA approves
the HTX-011 NDA as submitted; the anticipated commercial launch of
HTX-011; and other risks and uncertainties identified in the
Company's filings with the U.S. Securities and Exchange Commission.
Forward-looking statements reflect our analysis only on their
stated date, and Heron takes no obligation to update or revise
these statements except as may be required by law.
Investor Relations and Media Contact:
David Szekeres
Senior VP, General Counsel, Business Development and Corporate
Secretary
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.