SAN DIEGO, Dec. 3, 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 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. Health Canada's
Priority Review status provides an accelerated 6-month review
target for the NDS. Health Canada
grants Priority Review status to drug submissions intended for the
treatment, prevention or diagnosis of serious, life-threatening or
severely debilitating illnesses or conditions for which there is
substantial evidence of clinical effectiveness and a benefit/risk
profile that is improved over existing therapies.
"We are appreciative of Health Canada for granting Priority
Review status for the HTX-011 NDS," said Barry Quart, Pharm.D.,
President and Chief Executive Officer of Heron. "Priority Review
status was granted based on Health Canada's acknowledgement that
reduction in opioid prescribing and consumption is an important
medical and public health priority and that the benefit/risk
profile of HTX-011 is improved over existing therapies based on the
results of the two pivotal Phase 3 studies, EPOCH 1 and EPOCH 2, in
which HTX-011 demonstrated superior, longer-lasting pain relief
compared to bupivacaine with fewer patients using opioid
analgesics."
"The overprescribing of opioids after surgery puts surgical
patients at risk for opioid-related adverse events and potential
long-term use, which can result in unused pills making their way
into communities," said Dr. Ken
Leslie, Chief, Division of General Surgery, London Health
Sciences Centre, London, Ontario,
and Principal Investigator of the Standardization of Outpatient
Procedure (STOP) Narcotics Study. "New opioid-free options to more
effectively manage postoperative pain, while reducing the need for
opioids, are urgently needed, as opioid-related deaths have been on
the rise in Canada with more than
12,800 apparent opioid-related deaths occurring between
January 2016 and March 2019."
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
View original
content:http://www.prnewswire.com/news-releases/health-canada-grants-priority-review-status-for-heron-therapeutics-new-drug-submission-for-htx-011-for-management-of-postoperative-pain-300967802.html
SOURCE Heron Therapeutics, Inc.