SAN DIEGO, March 11, 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 31 patients undergoing
bunionectomy 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 bunionectomy that investigated HTX-011
without the OTC analgesic regimen, this study was led by one of the
lead investigators in the Phase 3 study and had the same entry
criteria as the Phase 3 study. The goal of the current study was to
increase the proportion of patients who did not require opioids by
combining HTX-011 with an OTC analgesic regimen.
Topline results of the study include the following:
- 77% 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 29%, 11% and 2% of
patients receiving HTX-011, bupivacaine solution and placebo,
respectively, in the Phase 3 study.
- 100% of patients receiving HTX-011 with the OTC analgesic
regimen who were opioid-free through 72 hours remained opioid-free
through 28 days post-surgery.
- The increase in patients who did not require opioids was
associated with a large reduction in the percentage of patients
experiencing severe pain. 29% of patients receiving HTX-011 with
the OTC analgesic regimen experienced severe pain, compared to 53%,
76% and 83% of patients receiving HTX-011, bupivacaine solution and
placebo, respectively, in the Phase 3 study.
- Over 72 hours post-surgery, patients receiving HTX-011 plus the
OTC analgesic regimen consumed an average of only 1.6 morphine
milligram equivalents (MME), which compares to 18.8 MME, 25.1 MME
and 30.1 MME for patients receiving HTX-011, bupivacaine solution
and placebo, respectively, in the Phase 3 study.
- HTX-011 was well tolerated with no serious adverse events
associated with the addition of the OTC analgesic regimen.
The results from this bunionectomy study complement the
opioid-free results from the hernia repair follow-up study reported
in January 2019. In this hernia
repair study, Heron reported that 90% of patients were opioid-free
72 hours post-surgery, and 81% were still opioid-free 28 days
post-surgery when receiving HTX-011 together with the OTC analgesic
regimen.
"In 2017, more than 47,000 individuals died due to an opioid
overdose in the U.S., an increase of more than 100% over the past
five years," said Richard Pollak,
D.P.M., M.S., Director of Endeavor Clinical Trials and Clinical
Assistant Professor, Podiatry Service, Department of Orthopedics at
the University of Texas Health Science
Center. "These recent study results suggest that HTX-011, if
approved, when combined with an OTC analgesic regimen, has the
potential to significantly reduce pain following surgery as well as
the percentage of patients that are discharged with opioids."
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 solution 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
pain or cancer.
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.