SAN DIEGO, Oct. 1, 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 it has resubmitted its
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for HTX-011, an investigational agent for the management of
postoperative pain. The Company anticipates a 6-month review by the
FDA.
The NDA for HTX-011 was resubmitted based on the outcome and
final minutes of a Type A meeting with the FDA, which was conducted
to obtain clarity on the Complete Response Letter (CRL) issued by
the FDA in April 2019. The CRL stated
that the FDA was unable to approve the NDA in its present
form based on the need for additional chemistry, manufacturing and
controls and non-clinical information.
"We are pleased to have reached agreement with the FDA on the
required information to include in the HTX-011 NDA resubmission to
address the CRL," said Barry Quart, Pharm.D., President and Chief
Executive Officer of Heron. "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 that can significantly reduce postoperative pain,
including severe pain, and help patients significantly reduce the
need for opioids."
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. 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.