SAN DIEGO, June 29, 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 received a Complete
Response Letter (CRL) from the U.S. Food and Drug Administration
(FDA) on June 26, 2020 regarding its
New Drug Application (NDA) for HTX-011 for the management of
postoperative pain.
The CRL stated that the FDA is unable to approve the NDA in its
present form based on the need for additional
non-clinical information. Based on the complete review of the NDA,
the FDA did not identify any clinical safety or efficacy issues or
CMC issues. There are four non-clinical issues in the CRL, none of
which relate to any observed toxicity. Three relate to confirming
exposure of excipients in preclinical reproductive toxicology
studies, and the fourth relates to changing the manufacturing
release specification of the allowable level of an impurity based
on animal toxicology coverage. We do not believe that any of the
issues are significant barriers to ultimate approval, as all of the
excipients have extensive histories of use in pharmaceuticals and
the specification can be revised. The Company will request a Type A
meeting to obtain agreement with the Agency on our responses and
resubmit the application as quickly as possible.
"We are committed to resolving the non-clinical issues outlined
in the CRL with the FDA and resubmitting an NDA as soon as possible
to bring this important non-opioid analgesic to patients," said
Barry Quart, Pharm.D., President and Chief Executive Officer of
Heron.
Conference Call and Webcast
Heron will host a conference call and webcast today, June
29, 2020, at 9:00 a.m. ET (6:00
a.m. PT). The conference call can be accessed by dialing
877-311-5906 for domestic callers and 281-241-6150 for
international callers. Please provide the operator with the
passcode 3252267 to join the conference call. The conference call
will be available via webcast under the Investor Relations section
of Heron's website at www.herontx.com. An archive of today's
teleconference and webcast will be available on Heron's website for
60 days following the call.
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 June 26, 2020 relating to non–clinical
information. No clinical safety or efficacy issues and no
chemistry, manufacturing and controls (CMC) issues were identified.
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; 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 Contact:
David Szekeres
Chief Legal, Business and Administrative Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.