SAN DIEGO, Oct. 28, 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 the U.S. Food
and Drug Administration (FDA) has accepted its New Drug Application
(NDA) resubmission for HTX-011, an investigational agent for the
management of postoperative pain. The FDA set a PDUFA goal date of
March 26, 2020.
"HTX-011 was designated by the FDA as a Breakthrough Therapy for
postoperative pain management and has the potential to be an
important new pain management option for patients, which has been
shown in Phase 3 clinical trials to significantly reduce
postoperative pain, including severe pain, and to significantly
reduce the need for opioids," said Barry Quart, Pharm.D., President
and Chief Executive Officer of Heron. "The recently reported
topline results from Study 306 in patients undergoing knee
replacement surgery who received HTX-011 as part of a common
multimodal analgesic regimen showed that patients maintained an
average pain score in the mild range for 72 hours after surgery
with only 25% receiving a prescription for opioids upon hospital
discharge. These results provide additional evidence that even in
large painful surgical procedures HTX-011 can help to reduce both
pain and the amount of opioid pills going out into society."
"There remains a significant need for a new, non-opioid
postoperative pain management option that can manage pain through
the 72 hours after surgery, when pain is most intense," said
Roy G. Soto, MD, Director of
Education and Anesthesiology Residency Program, Beaumont Health
System. "The surgical setting is a key place we can have a dramatic
impact on the opioid crisis, by reducing the amount of opioids used
after surgery and, ultimately, the number of unused pills in our
homes and communities."
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 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.
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 EMA Committee for
Medicinal Products for Human Use (CHMP) 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.