SAN DIEGO, Feb. 19, 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 the U.S. Food and Drug
Administration (FDA) has extended the review period for the New
Drug Application (NDA) for HTX-011 by up to three months. The new
PDUFA goal date is June 26, 2020.
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. Heron is pleased to report that the
contract manufacturing site used to manufacture HTX-011 has
been reinspected by the FDA with no Form 483 observations issued
and with a recommendation by the FDA inspector for approval of the
site. Heron has not been informed of any other manufacturing
concerns. There were no clinical efficacy or safety issues in the
CRL.
"While the three-month extension of the review clock for the
HTX-011 NDA resubmission is very disappointing, the FDA indicated
that they will try to complete their work in less time," said Barry
Quart, Pharm.D., President and Chief Executive Officer of Heron.
"We are gratified with the positive outcome of the FDA reinspection
of the HTX-011 contract manufacturing facility, which was an
important factor in the CRL."
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 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 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. The PDUFA goal date is June
26, 2020. A Marketing Authorisation Application for HTX-011 was
validated by the European Medicines Agency 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 FDA approves the NDA for HTX-011; the timing of the
commercial launch of HTX-011; the timing of the European Medicines
Agency Committee for Medicinal Products for Human Use review
process for HTX-011; whether the European
Commission authorizes the Marketing Authorisation Application
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
Chief Legal, Business, and Administrative Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.