SAN DIEGO, Dec. 31, 2018 /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 accepted the new drug application (NDA)
for Heron's investigational agent, HTX-011, and has granted it
a Priority Review designation. HTX-011 is a 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. HTX-011 is the first and only
dual-action fixed-combination product specifically designed to
address both postoperative pain and inflammation in a single
administration at the surgical site. The NDA for HTX-011, which was
submitted on October 30, 2018,
comprises data from five Phase 2 clinical trials and two Phase 3
clinical trials that included over 1,000 patients undergoing five
different surgical procedures. The FDA also indicated that it is
not currently planning to hold an advisory committee meeting to
discuss this application. The FDA set a Prescription Drug User Fee
Act goal date of April 30, 2019.
"We are pleased to receive Priority Review designation for the
HTX-011 NDA," said Barry D. Quart, Pharm.D., Chief Executive
Officer 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 and
receive opioids after surgery, especially at discharge. We look
forward to continuing to work closely with the FDA during the
review process with the goal of bringing this important product to
patients in 2019."
The FDA had previously granted Breakthrough Therapy designation
for HTX-011 based on the results of Phase 2 studies and two
completed Phase 3 studies, which showed that HTX-011 produced
significant reductions in both pain intensity and the need for
opioids through 72 hours post-surgery compared to placebo and
bupivacaine solution, the standard-of-care. The FDA has now granted
Priority Review designation to the NDA for HTX-011. Priority Review
designation is for drugs that, if approved, would be significant
improvements in the safety or effectiveness of the treatment or
prevention of serious conditions. HTX-011 is the first and only
non-opioid, long acting local anesthetic to demonstrate in Phase 3
studies a statistically significant reduction in severe pain and an
increase in the number of patients who require no opioids for 72
hours postoperatively versus bupivacaine solution, the
standard-of-care. The overall safety profile of HTX-011,
administered locally into the surgical site without a needle, was
similar to that of the well-established safety profile of
bupivacaine solution, without evidence of meloxicam-related
toxicities.
"Despite ongoing efforts to prevent opioid abuse, patients
continue to receive large quantities of opioids for postsurgical
pain," said Jay Redan, M.D., FACS, Medical Director of
Minimally-Invasive General Surgery at Florida Hospital Celebration
Health. "There is a significant need for safe, effective
and non-addictive options that can decrease opioid exposure and
improve the patient recovery experience, as well as make an impact
on the opioid epidemic by significantly reducing the amount of
opioids necessary to take home for pain management."
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 alone 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
2018. The FDA set a Prescription Drug User Fee Act goal date
of April 30, 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
cancer or pain.
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 FDA's review
process for HTX-011; whether the FDA will require an advisory
committee meeting for HTX-011 in the future; the anticipated
commercial launch of 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.