SAN DIEGO, May 14, 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 93 patients that provides
real-world evidence of opioid-free recovery in patients undergoing
outpatient inguinal hernia repair surgery who received the
investigational agent, HTX-011, together with a scheduled
background regimen of generic over-the-counter (OTC) oral
analgesics (acetaminophen and ibuprofen). This study is the initial
phase of the HOPE (Helping Opioid Prescription
Elimination) Project, which is designed to substantially
reduce opioid prescriptions following surgery with HTX-011 as the
foundation of a multimodal analgesic regimen. Currently, the
average patient in the U.S. undergoing inguinal hernia repair
surgery receives a discharge prescription for 30 opioid
pills. Patients in this real-world outpatient study were
discharged approximately 2-3 hours following surgery, and those who
met prespecified criteria were discharged without a prescription
for opioid analgesics.
The goal of this study was to provide real-world confirmation of
the treatment algorithm developed in our Phase 3 hernia repair
surgery follow-on study (Study 215), in which 90% of patients
receiving HTX-011 with an OTC analgesic regimen remained
opioid-free during a 72-hour inpatient assessment period, and to
optimize the OTC analgesic regimen used with HTX-011.
Topline results of the study include the following:
- 95% of patients receiving HTX-011 with the OTC analgesic
regimen did not require opioids to manage their postoperative pain
through recovery (Day 15).
- 91% of patients receiving HTX-011 with the OTC analgesic
regimen were discharged without an opioid prescription, and none of
these patients subsequently requested an opioid for postoperative
pain.
- HTX-011 was well tolerated with no serious adverse events
associated with the addition of the OTC analgesic regimen.
- Patients indicated an overall high satisfaction with the
HTX-011-based analgesic regimen.
"Postoperative pain remains a major problem for surgical
patients, and there have been few effective and innovative
non-opioid advances for patients who want adequate pain relief
without relying on opioids," said Michael
Reinhorn, MD, MBA, FACS, President, Boston Hernia &
Pilonidal Center. "These results provide evidence that HTX-011 may
be an important tool that will allow healthcare providers to
significantly reduce the use of unnecessary postoperative opioids
and have a substantial impact on the opioid crisis we are facing in
the U.S."
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. A Complete
Response Letter was received from the FDA regarding the NDA for
HTX-011 on April 30, 2019 relating to
chemistry, manufacturing and controls and non-clinical information.
No issues related to clinical efficacy or safety were noted. A
Marketing Authorisation Application for HTX-011 was validated
by the European Medicines Agency in March 2019 for review under the Centralised
Procedure.
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 NDA for HTX-011; the timing of the commercial launch of
HTX-011; the timing of the CHMP's review process for HTX-011;
whether the European Commission authorizes the MAA for 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.