SAN DIEGO, Oct. 2, 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 positive topline results of a
multi-center postoperative pain management study in which 51
patients undergoing total knee arthroplasty (TKA) surgery received
the investigational agent, HTX-011, together with a scheduled
postoperative regimen of generic, oral analgesics (acetaminophen
and celecoxib). A follow-on study to the Phase 2b study of HTX-011 in TKA (Study 209) that was
completed in 2018, this study was designed to evaluate the decrease
in pain and opioid use with HTX-011 when used together with a
regimen of generic oral analgesics. In Study 209, HTX-011
significantly reduced pain and opioid use compared to placebo
through 72 hours and significantly reduced pain compared to
bupivacaine solution, the current standard-of-care local anesthetic
for postoperative pain control, using a last observation carried
forward (LOCF) analysis. The Phase 3b
study included the same multimodal, oral analgesic regimen as a
prior published study with liposomal bupivacaine in TKA (Mont doi:
10.1016/j.arth.2017.07.024).
Topline results of this Phase 3b
study include the following:
- Mean pain scores remained in the mild range through 72 hours
post-surgery.
- Median consumption of opioids was 4-to-5 pills of oxycodone
(22.5 morphine milligram equivalents) through 72 hours.
- 75% of patients were discharged from the hospital without a
prescription for opioids.
- HTX-011, together with the multimodal, oral analgesic regimen,
was well tolerated in this study. There were no deaths, serious
adverse events or premature discontinuations due to adverse
events.
These Phase 3b study results in
TKA complement the positive results of HTX-011 studies in hernia
repair and bunionectomy. In January
2019, Heron reported that 90% of patients who received
HTX-011 together with a regimen of over-the-counter (OTC) oral
analgesics (acetaminophen and ibuprofen) did not require opioids
through 72 hours post-hernia repair surgery. In March 2019, Heron reported that 77% of patients
that received HTX-011 together with the OTC oral analgesic regimen
did not require opioids through 72 hours post bunionectomy.
"Without appropriate multimodal analgesic postoperative pain
management, TKA is usually a very painful procedure, especially for
patients with end-stage arthritis," said Paul Lachiewicz, M.D., Consulting Professor,
Department of Orthopedic Surgery, Duke
University. "This study provides strong evidence that
HTX-011, together with a standard multimodal analgesic pain
regimen, may play an essential role in not only providing superior
pain relief with reduction of severe pain, but also reducing opioid
consumption and the need for opioid discharge prescriptions for
patients undergoing TKA. With the majority of patients only
requiring 4-to-5 opioid pills and 75% being discharged without an
opioid prescription, these results also demonstrate that new
innovative non-opioid pain medications, like HTX-011, can
substantially improve patient care, change current prescribing
practices and help to stem the overreliance on opioids after major
orthopedic surgery."
"In 2017, more than 47,000 individuals died due to an opioid
overdose in the U.S. This dire statistic is fueled by the more than
one-billion opioid pills prescribed to patients following surgery
and the lack of effective alternative regimens," said Barry Quart,
Pharm.D., President and Chief Executive Officer of Heron. "The
results from recent studies in TKA, hernia repair and bunionectomy
demonstrate that HTX-011 can effectively reduce pain and allow the
majority of patients to be discharged without opioids."
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 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. 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.
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 EMA Committee for
Medicinal Products for Human Use (CHMP) review process for HTX-011;
whether the European Commission 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.