SAN DIEGO, May 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 received a Complete
Response Letter (CRL) from the U.S. Food and Drug Administration
(FDA) on April 30, 2019 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 CMC and non-clinical
information. Based on the complete review of the NDA, the FDA did
not identify any clinical safety or efficacy issues, and there is
no requirement for further clinical studies or data analyses.
"We plan to request a meeting with the FDA to obtain its
agreement on our approach to resolve the issues outlined in the CRL
and resubmit the NDA as soon as possible," said Barry Quart,
Pharm.D., President and Chief Executive Officer of Heron
Therapeutics.
Conference Call and Webcast
Heron Therapeutics will host a conference call and webcast
today, May 1, 2019, at 8:30 a.m. ET (5:30 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 9591606 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, which utilizes Heron's proprietary
Biochronomer® drug delivery technology, is an
investigational, long-acting, extended-release formulation of the
local anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam for the management of postoperative
pain. By delivering sustained levels of both a potent anesthetic
and a local anti-inflammatory agent directly to the site of tissue
injury, HTX-011 was designed to deliver superior pain relief while
reducing the need for systemically administered pain medications
such as opioids, which carry the risk of harmful side effects,
abuse and addiction. HTX-011 has been shown to reduce pain
significantly better than placebo or bupivacaine solution in five
diverse surgical models: hernia repair, abdominoplasty,
bunionectomy, total knee arthroplasty and breast augmentation.
HTX-011 was granted Fast Track designation from the FDA in the
fourth quarter of 2017 and Breakthrough Therapy designation in the
second quarter of 2018. Heron submitted an NDA to
the FDA for HTX-011 in October of 2018 and received
Priority Review designation in December of 2018. A CRL was received
from the FDA regarding the NDA for HTX-011 on April 30, 2019. An MAA for HTX-011 was validated
by the 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 HTX-011 NDA; the timing of the commercial launch of HTX-011;
the timing of the CHMP's review process for HTX-011; whether the
EMA 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 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.