SAN DIEGO, April 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 the Marketing
Authorisation Application (MAA) for its investigational agent,
HTX-011, for postoperative pain, was validated by the European
Medicines Agency (EMA). Validation of the MAA confirms that the
submission is complete and starts the EMA's Centralised Procedure.
The EMA granted eligibility to the Centralised Procedure for
HTX-011 based on it meeting the criteria of a medicinal product
constituting a significant scientific innovation. The Centralised
Procedure allows applicants to receive a marketing authorisation
that is valid throughout the European Union (EU). With the
validation of the MAA, an opinion from the EMA Committee for
Medicinal Products for Human Use (CHMP) would be anticipated in the
first half of 2020.
HTX-011 is the first and only dual-acting local anesthetic.
HTX-011's novel mechanism of action combines bupivacaine with
low-dose meloxicam to overcome the challenges of the inflammatory
process at the surgical site. HTX-011 has significantly reduced
severe pain and the need for opioids better than standard-of-care
bupivacaine solution over 72 hours following surgery.
The MAA for HTX-011 is supported by data from 7 completed Phase
2 and Phase 3 studies in more than 1,000 subjects across 5
different surgical models, which are also included in the New Drug
Application (NDA) Heron submitted to the U.S. Food and Drug
Administration (FDA).
HTX-011 is the only non-opioid pain medication to have been
granted Fast Track designation, Breakthrough Therapy designation
and Priority Review designation by the FDA. The FDA set a
Prescription Drug User Fee Act (PDUFA) goal date of April 30, 2019 for the HTX-011 NDA.
"Improved post-operative pain management remains as much an
unmet need in Europe as
elsewhere," said Professor Richard
Langford, Lead Consultant in Pain Medicine, The London
Clinic and Chief Medical Officer, St Pancras Clinical Research.
"Too many patients still report unacceptable levels of pain after
surgery and side effects from opioids, resulting in delayed
discharge and recovery and increasing the risk of complications and
poorer overall treatment outcomes. Regimens that are easy to use
and provide meaningful patient benefit
through uninterrupted, effective pain management, particularly
in the first few days after surgery, are required. I believe
that HTX-011 shows tremendous promise in postoperative pain
management and has the potential to change the treatment paradigm
for postoperative pain in European practice."
"We are pleased that our MAA for HTX-011 was validated by the
EMA," said Kimberly Manhard,
Executive Vice President, Drug Development of Heron. "We believe
that HTX-011 could have a considerable impact on the lives of
patients by significantly reducing the proportion of patients who
experience severe pain. We look forward to working closely with the
EMA during the review process with the goal of bringing this
important product to patients."
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. The FDA set a
PDUFA goal date of 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 as submitted; 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 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.