SAN DIEGO, May 18, 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 it has
initiated a Phase 1b/2 clinical study
in patients undergoing bunionectomy of HTX-034, Heron's
next-generation product for the treatment of postoperative pain.
The study initiation follows clearance from the U.S. Food and Drug
Administration (FDA) of Heron's Investigational New Drug
application for HTX-034 for the treatment of postoperative
pain.
HTX-034, an investigational non-opioid, is a fixed-dose
combination, extended-release solution of the local
anesthetic bupivacaine, the nonsteroidal
anti-inflammatory drug meloxicam and an additional agent
that further potentiates the activity of
bupivacaine. HTX-034 is formulated in the same
proprietary polymer as HTX-011. HTX-034 is designed to provide
superior and prolonged analgesia and enhance the activity of the
local anesthetic bupivacaine via two different mechanisms. Local
administration of HTX-034 in a validated preclinical postoperative
pain model resulted in sustained analgesia for 7 days.
The HTX-034 study is a randomized, active-controlled,
double-blinded, Phase 1b/2 study in
patients undergoing bunionectomy with an osteotomy and internal
fixation. The study will evaluate the safety and efficacy of
HTX-034 compared to bupivacaine solution, the current
standard-of-care local anesthetic for postoperative pain control.
The Phase 1b portion of the study is
intended to select the optimal dose for the Phase 2 expansion
portion.
"We are excited to progress HTX-034 into a proof-of-concept
study in patients undergoing bunionectomy, a highly painful
surgery, where we have the opportunity to evaluate the magnitude
and duration of analgesia," said Barry Quart, Pharm.D., President
and Chief Executive Officer of Heron. "In the same highly
predictive animal model where we optimized HTX-011, HTX-034 has
shown enhanced analgesic benefit for 7 days after surgery."
About HTX-034 for Postoperative Pain
HTX-034, an investigational non-opioid, is a fixed-dose
combination, extended‑release solution of the local anesthetic
bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam
and an additional agent that further potentiates the activity
of bupivacaine. HTX-034 is formulated in the same proprietary
polymer as HTX-011. By combining two different mechanisms that each
enhance the activity of the local anesthetic bupivacaine, HTX-034
is designed to provide superior and prolonged analgesia. Local
administration of HTX-034 in a validated preclinical postoperative
pain model resulted in sustained analgesia for 7 days.
About HTX-011 for Postoperative Pain
HTX-011, an investigational non-opioid, 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. The Prescription Drug User Fee
Act (PDUFA) goal date is June 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 U.S. 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's (EMA)
Committee for Medicinal Products for Human Use (CHMP) review
process for HTX-011; whether the European Commission
(EC) authorizes the Marketing Authorisation 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; the timing and
results of studies for the HTX-034 development program; 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.