SAN DIEGO, June 4, 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 results from Study
209, a Phase 2b study of the
investigational agent HTX-011 in primary unilateral total knee
arthroplasty (TKA), have been published online by The Journal of
Arthroplasty in an article entitled "HTX-011 Reduced Pain and
Opioid Use After Primary Total Knee Arthroplasty: Results of a
Randomized Phase 2b Trial." All
primary and key secondary endpoints in Study 209 were achieved,
with HTX-011 demonstrating statistically significant reductions in
pain intensity following surgery.
HTX-011 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.
In Study 209, patients undergoing primary unilateral TKA who
received a single, needle-free application of
HTX-011 demonstrated superior pain reduction when compared to
patients receiving placebo or bupivacaine solution through 48 and
72 hours. In addition, patients receiving HTX–011 consumed
fewer opioids when compared to patients receiving placebo or
bupivacaine solution. Fewer patients receiving HTX-011 had
severe pain through 72 hours, and more patients receiving
HTX-011 were deemed ready for discharge at 8, 12 and 24 hours,
both as compared to patients receiving placebo or bupivacaine
solution. HTX-011 was well tolerated in Study 209, with a safety
profile comparable to placebo and bupivacaine solution.
"Effective pain management is crucial after TKA to permit
earlier mobilization, maximize patient satisfaction and facilitate
outpatient surgery," said Alan J.
Rechter, M.D., an orthopedic surgeon at Orthopaedic
Associates, LLP. "Based on my experience in Study 209, the fast and
easy needle-free administration of HTX-011 provided patients with
effective and improved pain control despite taking fewer
opioids."
The Journal of Arthroplasty article can be found
here.
About Study 209
Study 209 was a randomized, placebo- and active-controlled,
double-blind, Phase 2b clinical study
in patients undergoing primary unilateral total knee arthroplasty
to evaluate the analgesic efficacy, safety and pharmacokinetics of
HTX-011 locally administered into the surgical site. Following a
dose-escalation phase, 232 patients were randomized, and 222
patients received treatment with: (1) HTX-011 400 mg bupivacaine/12
mg meloxicam administered via instillation into the surgical site;
(2) HTX-011 400 mg bupivacaine/12 mg meloxicam administered via
instillation into the surgical site plus a low dose of ropivacaine
solution injected into the posterior capsule; (3) bupivacaine
solution 125 mg administered via multiple injections into the
surgical site; or (4) placebo. Ropivacaine solution and bupivacaine
solution are generically available standard-of-care local
anesthetics used in the management of postoperative pain. This
study included a pre-specified hierarchical testing strategy for
the primary and key secondary endpoints for the HTX-011 400 mg
bupivacaine/12 mg meloxicam treatment groups. The primary endpoint
was pain intensity as measured by the Area Under the Curve (AUC)
from 0 to 48 hours post-surgery (AUC 0-48) for HTX-011 compared to
placebo. The primary and key secondary endpoints were achieved:
- HTX-011 alone and in combination with ropivacaine solution
resulted in reductions of 19% and 22%, respectively, in pain
intensity through 48 hours when compared to placebo (p=0.0002 and
p<0.0001, respectively).
- HTX-011 alone and in combination with ropivacaine solution
resulted in reductions of 18% and 22%, respectively, in pain
intensity through 72 hours when compared to placebo (p=0.0004 and
p<0.0001, respectively).
- Sensitivity analyses using patient-reported pain scores
without adjustment for opioid use confirmed that HTX-011 alone and
in combination with ropivacaine solution resulted in reductions of
29% and 27%, respectively, in pain intensity through 48 hours,
and 28% and 26%, respectively, in pain intensity through
72 hours when compared to placebo (p≤0.0002 for both
comparisons).
- Sensitivity analyses using patient-reported pain scores
without adjustment for opioid use confirmed that HTX-011 alone and
in combination with ropivacaine solution resulted
in reductions of 19% and 17%, respectively, in pain
intensity through 48 hours, and 17% and 16%, respectively, in pain
intensity through 72 hours when compared to bupivacaine
solution (P<0.05 for both comparisons).
- Total opioid consumption for HTX-011 alone or in combination
with ropivacaine solution was lower over 24, 48 and 72 hours when
compared to placebo or bupivacaine solution.
HTX-011 was well tolerated in Study 209, with a safety profile
comparable to placebo and bupivacaine solution.
About HTX-011 for Postoperative Pain
HTX-011, an investigational non-opioid, 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. The Prescription Drug User Fee
Act (PDUFA) goal date is June 26,
2020. 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. 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 U.S. Food
and Drug Administration (FDA) approves the New Drug
Application (NDA) for HTX-011; the timing of the commercial launch
of HTX-011; the timing of the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) review
process for HTX-011; whether the European Commission
(EC) authorizes the Marketing Authorisation Application (MAA)
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
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.