SAN DIEGO, Sept. 16, 2020 /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 that the results from EPOCH 2
follow-on study (NCT03695367) of the investigational agent HTX-011
in open inguinal hernia repair surgery with mesh, have been
published online by the journal, Surgery in an article
entitled "Opioid-free recovery following herniorrhaphy with HTX-011
as the foundation of a multimodal analgesic regimen." In this
study, more than 90% of patients receiving HTX-011, along with
postoperative over-the-counter (OTC) acetaminophen and ibuprofen,
remained opioid-free throughout the 72-hour period following hernia
repair surgery. The mean pain intensity never rose above the mild
range through 72 hours following surgery.
HTX-011 is a dual-acting, fixed-dose combination of the local
anesthetic bupivacaine with a low dose of the nonsteroidal
anti-inflammatory drug meloxicam. It is the first and only
extended–release local anesthetic to demonstrate in Phase 3 studies
(EPOCH 1 in bunionectomy and EPOCH 2 in hernia repair)
significantly reduced pain and opioid use through 72 hours compared
to bupivacaine solution, the current standard–of–care local
anesthetic for postoperative pain control. HTX-011 was well
tolerated, with a safety profile comparable to placebo and
bupivacaine solution.
"Typically, the first 72 hours after surgery are the most
difficult from a pain management perspective and is where patients
experience the most severe pain requiring opioids," said
Jay Redan, M.D., Chief of Surgery at
AdventHealth Celebration. "The EPOCH 2 follow-on study provides
important evidence that HTX-011, along with OTC analgesics, can
keep patients in the mild pain range, allowing more than 90% to
remain opioid-free. The study was able to identify patients who
should receive an opioid discharge prescription and has the
potential to personalize postoperative pain management so that
opioids are only prescribed to those who will need them after
discharge. This can help to substantially limit the amount of
opioids going home with patients following hernia repair
surgery."
The Surgery article can be found here.
About the EPOCH 2 Follow-On Study
The EPOCH 2 follow-on study was a multicenter, postoperative
pain management study evaluating the efficacy and safety of locally
administered HTX-011 300 mg bupivacaine / 9 mg meloxicam via
needle-free application into the surgical site in combination with
a postoperative non-opioid multimodal analgesia (MMA) regimen of
over-the-counter oral acetaminophen and ibuprofen in 63 patients.
The study included two sequential cohorts, with identical
procedures and MMA regimens, except that patients in Cohort 2
also received an intraoperative dose of ketorolac (15 mg or 30 mg,
based on age, renal function and weight) prior to wound closure.
The goal was to increase the proportion of opioid-free patients by
combining HTX-011 with a postoperative regimen of readily
available, oral analgesics. Key results of the study include the
following:
- In total, more than 90% of patients in this study did not
require opioids to manage their postoperative pain during the first
72 hours.
- Across all study patients, 87% were opioid-free through Day 10
and 83% were opioid-free throughout the entire 28-day follow-up
period of the study.
- Patients in the study who required an opioid during the 72-hour
postoperative period could be identified retrospectively with the
following algorithm: pain score ≥6 at 2 hours postoperatively or
received opioid rescue medication within the first 2 hours
postoperatively.
- Mean pain intensity scores were similar between cohorts and
never rose above the mild pain range (NRS <4) throughout the
72-hour postoperative period.
- Addition of an intraoperative dose of ketorolac did not provide
additional benefit for pain intensity or opioid use.
HTX-011 was well tolerated, and co-administration with
non-steroidal anti-inflammatory drugs did not affect the
safety of HTX-011.
About HTX-011 for Postoperative Pain
HTX-011, an investigational non-opioid analgesic, is a
dual-acting, fixed-dose combination of the local anesthetic
bupivacaine with a low dose of the nonsteroidal anti-inflammatory
drug meloxicam. It is the first and only extended-release
local anesthetic to demonstrate in Phase 3 studies significantly
reduced pain and opioid use through 72 hours compared to
bupivacaine solution, the current standard-of-care local anesthetic
for postoperative pain control. HTX-011 was granted
Breakthrough Therapy designation and received Priority Review
designation. A complete response letter (CRL) was received from the
U.S. Food and Drug Administration (FDA) regarding the New Drug
Application (NDA) for HTX-011 in June
2020 relating to non–clinical information. No clinical
safety or efficacy issues and no chemistry, manufacturing and
controls (CMC) issues were identified. The European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) adopted a positive opinion for HTX-011 under the proprietary
name ZYNRELEFTM in July 2020. Heron's New Drug
Submission (NDS) for HTX-011 for the management of postoperative
pain was granted Priority Review status and accepted by Health
Canada. Heron is working to respond to a list of questions received
from Health Canada in July 2020.
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: the timing of the NDA
resubmission to the FDA; whether the FDA approves the NDA for
HTX-011; the timing of the commercial launch of HTX-011 in the
U.S.; the timing of the European Commission's (EC) review process
for ZYNRELEF; whether the EC authorizes the Marketing
Authorisation Application for ZYNRELEF; the timing of the
commercial launch of ZYNRELEF in Europe; the timing of Health Canada's NDS
review process for HTX-011; whether Health Canada issues a
Notice of Compliance for the NDS for HTX-011; the extent of the
impact of the ongoing Coronavirus Disease 2019 (COVID-19) pandemic
on our business; 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
Chief Legal, Business and Administrative Officer
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.