-Pain intensity through 24 hours reduced by 69%
-Pain
intensity through 72 hours reduced by 40%
-Time to first use
of opiate rescue medication increased by 488%
-32% of
patients received no opiate rescue through 72 hours compared to 5% for
placebo
Conference call and webcast at 8:30 am ET on September 23
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Sep. 22, 2015--
Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused
on improving the lives of patients by developing best-in-class medicines
that address major unmet medical needs, today announced positive,
top-line results from its Phase 2 clinical study of HTX-011 in the
management of post-operative pain in patients undergoing bunionectomy.
HTX-011, which utilizes Heron’s proprietary Biochronomer®
drug delivery technology, is a long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam. The primary and all key secondary endpoints
in the study were met with a high degree of statistical significance.
This randomized, placebo-controlled, double-blind, Phase 2 clinical
study in 64 patients undergoing bunionectomy evaluated the efficacy and
safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined
with meloxicam, compared to placebo. The primary endpoint was the
difference as compared to placebo in pain intensity as measured by the
Summed Pain Intensity (SPI) score in the first 24 hours post-surgery
(SPI 0-24). Key secondary endpoints included: the difference in SPI in
the first 48 hours post-surgery (SPI 0-48); the difference in SPI in the
first 72 hours post-surgery (SPI 0-72); time to the first use of opiate
rescue medication; and the percent of patients who received no opiate
rescue medication in the first 72 hours post-surgery. The study’s major
efficacy findings for the more effective, 400 mg dose of HTX-011 as
compared to placebo include:
-
Pain intensity in the first 24 hours post-surgery was reduced by 69%
(SPI of 38.5 versus 124.2, p<0.0001).
-
Pain intensity in the first 48 hours post-surgery was reduced by 52%
(SPI of 106.9 versus 224.8, p<0.0001).
-
Pain intensity in the first 72 hours post-surgery was reduced by 40%
(SPI of 170.2 versus 285.9, p=0.0064).
-
Time to the first use of opiate rescue medication was increased by
488% (48.2 hours versus 8.2 hours, p<0.0001).
-
32% of patients received no opiate rescue medication during the entire
72-hour period post-surgery, compared to 5% for placebo (p<0.0001).
HTX-011 was generally well tolerated in the study. The most frequent
adverse events reported were headache, nausea, vomiting, erythema,
cellulitis, dizziness, and hypoxia, none of which were considered
drug-related.
“Although opioid analgesics are standard of care for post-operative pain
management, too often they are associated with unacceptable adverse
effects often prolonging hospitalization and recovery,” stated Jeffrey
A. Gudin, MD, Director, Pain Management and Palliative Care, Englewood
Hospital and Medical Center, Englewood, NJ. “Thus, there is a major
unmet need for a pain management treatment that can substantially reduce
our dependence on post-operative opioids. The ability of HTX-011,
administered once during surgery, to significantly reduce pain and the
need for pain medications for three days following surgery (as compared
to a control group) is truly promising.”
“At Heron, we are dedicated to the development of best-in-class
medicines that can have a major impact on patients’ lives,” commented
Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We are very
pleased with these results, and we now will turn our attention to
executing on a broad-based development program designed to enable us to
bring HTX-011 to the many patients undergoing a wide range of surgeries
who experience significant post-operative pain.”
Conference Call and Webcast
Heron Therapeutics will host a conference call and webcast on Wednesday,
September 23 at 8:30 a.m. ET (5:30 a.m. PT). The conference call can be
accessed by dialing (877) 311-5906 for domestic callers and (281)
241-6150 for international callers. Please provide the operator with the
passcode 46461973 to join the conference call. The conference call will
also be available via webcast under the investor relations section of
Heron's website at www.herontx.com
and will be archived there for 90 days following the call. Please
connect to Heron's website several minutes prior to the start of the
broadcast to ensure adequate time for any software download that may be
necessary.
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer®
drug delivery technology, is a long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam for the prevention of post-operative pain.
By delivering sustained levels of both a potent anesthetic and an
anti-inflammatory agent directly to the site of tissue injury, HTX-011
was designed to deliver superior pain relief while potentially reducing
the need for systemically administered pain medications such as opioids,
which carry the risk of harmful side effects, abuse and addiction. In
September 2015, Heron reported positive top-line results from a Phase 2
study of HTX-011 in patients undergoing bunionectomy. In this study,
HTX-011 significantly reduced pain intensity, significantly reduced the
need for opioid rescue medications, and significantly increased the time
to first use of rescue medications. HTX-011 is the subject of a
broad-based development program designed to target the many patients
undergoing a wide range of surgeries who experience significant
post-operative pain.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a biotechnology company focused on improving
the lives of patients by developing best-in-class medicines that address
major unmet medical needs. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents. Heron’s goal is to build on
therapeutics with well-known pharmacology by improving their
tolerability and efficacy as well as broadening their potential field of
use. Heron is currently developing four pharmaceutical products for
patients suffering from cancer or pain. SUSTOL® (granisetron)
Injection, extended release is being developed for the prevention of
both acute and delayed chemotherapy-induced nausea and vomiting (CINV)
associated with moderately emetogenic chemotherapy (MEC) or highly
emetogenic chemotherapy (HEC). CINV is one of the most debilitating side
effects of chemotherapy and is a leading cause of premature
discontinuation of cancer treatment. Heron recently reported positive,
top-line results from its Phase 3 MAGIC study. In July 2015, Heron
resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food
and Drug Administration (FDA), and the FDA has assigned a Prescription
Drug User Fee Act (PDUFA) goal date of January 17, 2016. HTX-019, also
being developed for the prevention of CINV, has the potential to become
the first polysorbate 80-free, intravenous formulation of aprepitant, a
neurokinin-1 (NK1) receptor antagonist. Heron intends to file
an NDA for HTX-019 using the 505(b)(2) regulatory pathway in the second
half of 2016. HTX-011 is Heron’s long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam. In September 2015, Heron reported positive,
top-line results from a Phase 2 study of HTX-011 in patients undergoing
bunionectomy. In this study, HTX-011 significantly reduced pain
intensity and the need for opioid rescue medications. HTX-011 is the
subject of a broad-based development program designed to target the many
patients undergoing a wide range of surgeries who experience significant
post-operative pain. HTX-003, a long-acting formulation of
buprenorphine, is being developed for the potential management of
chronic pain and opioid addiction. All of Heron’s product candidates
utilize Heron’s innovative science and technology platforms, including
its proprietary Biochronomer® drug delivery technology, which
can deliver therapeutic levels of a wide range of otherwise short-acting
pharmacological agents over a period of days to weeks with a single
injection.
For more information, please 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. These risks and uncertainties include, but
are not limited to, those associated with: whether the U.S. Food and
Drug Administration (FDA) approves the SUSTOL NDA as submitted or
supports as broad of a labeled indication for SUSTOL as requested, the
progress in the research and development of HTX-019, HTX-011, HTX-003
and our other programs, including the timing of preclinical, clinical,
and manufacturing activities, safety and efficacy results from our
studies that may not justify the pursuit of further development of our
product candidates, the launch and acceptance of SUSTOL and new products
generally, our financial position and our ability to raise additional
capital to fund operations, if necessary, or to pursue additional
business opportunities, strategic business alliances we may pursue or
the potential acquisition of products or technologies, and our ability
to grow our organization to sustain the commercial launch for SUSTOL,
and other risks and uncertainties identified in the Company's filings
with the 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150922006409/en/
Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
Associate Director, Investor Relations
jcapuzelo@herontx.com
or
Corporate
Contact:
Barry D. Quart, Pharm D., 650-366-2626
Chief
Executive Officer