SAN DIEGO, Dec. 16, 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 that data supporting
the novel mechanism of action for the investigational agent HTX-011
have been published online by the Regional Anesthesia & Pain
Medicine (RAPM) journal, in an article entitled "Mechanism
of action of HTX-011: a novel, extended-release, dual-acting local
anesthetic formulation for postoperative pain."
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 in a proprietary
Biochronomer® polymer. 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.
The synergistic mechanism of action of HTX-011 was demonstrated
in preclinical and clinical studies. Preclinical research in a
validated postoperative pig model demonstrated the ability of the
low-dose of meloxicam combined with bupivacaine in HTX-011 to
address local tissue inflammation at the surgical site, as
demonstrated by a less acidic tissue pH level. This maintenance of
the physiologic pH level within the surgical site microenvironment
was associated with potentiated and prolonged analgesic activity of
bupivacaine. The synergy of the low-dose meloxicam combined with
bupivacaine in HTX-011 was further confirmed in a Phase 2
bunionectomy study, where HTX-011 achieved superior and sustained
pain relief through 72 hours after surgery compared to the
Biochronomer polymer formulation of bupivacaine alone, while the
Biochronomer polymer formulation of meloxicam alone produced no
appreciable pain relief.
"The inability of local anesthetics, including current extended
release formulations, to demonstrate consistent postoperative pain
relief beyond 24 hours creates challenges for both physicians and
patients. This may lead them to use opioids to fill the analgesic
gap following surgery," said Eugene
Viscusi, M.D., Professor of Anesthesiology and Chief of Pain
Medicine in the Department of Anesthesiology at the Sidney Kimmel
Medical College of Thomas Jefferson
University in Philadelphia,
Pennsylvania. "By normalizing pH levels within the inflamed
tissue, more bupivacaine is able to penetrate the nerve membrane,
prolonging the analgesic activity of HTX-011. The extended delivery
of effective pain relief over the course of 72 hours following
surgery may allow physicians to manage pain with less reliance on
opioids."
The Regional Anesthesia and Pain Medicine
article can be found here.
About HTX-011 for Postoperative Pain
HTX-011, an investigational agent, 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 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 (CRL) 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. Heron
resubmitted an NDA to the FDA for HTX-011 in September 2019 and the FDA set a Prescription
Drug User Fee Act (PDUFA) goal date of March
26, 2020. A Marketing Authorisation Application (MAA) for
HTX-011 was validated by the European Medicines Agency (EMA) in
March 2019 for review under the
Centralised Procedure. Heron's New Drug Submission (NDS) for
HTX-011 for the management of postoperative pain was granted
Priority Review status by Health Canada in October 2019 and accepted by Health
Canada in November 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 United
States Food and Drug Administration (FDA) approves the New
Drug Application (NDA) for HTX-011; the timing of the commercial
launch of HTX-011; the timing of the European Medicines Agency
(EMA) Committee for Medicinal Products for Human Use
(CHMP) review process for HTX-011; whether the European
Commission authorizes the Marketing Authorization Application
(MAA) for HTX-011; the timing of Health Canada's New Drug
Submission (NDS) review process for HTX-011; whether Health
Canada issues a Notice of Compliance for the NDS 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.