Full Press Release Details
HERON ANNOUNCES POSITIVE TOPLINE RESULTS FROM PIVOTAL PHASE 3 CLINICAL TRIALS OF HTX-011 IN BUNIONECTOMY AND HERNIA REPAIR
Achieved All Primary and Key Secondary Endpoints-
-HTX-011 Produced Statistically
Significant Reductions in Both Pain Intensity and Need for Opioids through 72 hours Post-Surgery Compared to Placebo and Bupivacaine Solution, the Standard-of-Care-
- Significantly More Patients Receiving HTX-011 Were Opioid-Free through 72 hours after
Surgery and Significantly Fewer HTX-011 Patients Experienced Severe Pain at Any Time -
NDA Filing Targeted for 2H 2018 -
- Conference Call and Webcast Today at 8:30 a.m. ET -
SAN DIEGO, Calif. (BUSINESS WIRE) March 19, 2018 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 from its completed Phase 3 studies of the investigational agent HTX-011 in subjects undergoing bunionectomy (Study 301/EPOCH1) and hernia repair (Study 302/EPOCH2).
HTX-011 achieved all primary and key secondary endpoints in both Phase 3 trials, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72
hours following surgery.
HTX-011 is the first and only long-acting local anesthetic to demonstrate in Phase 3
studies significantly reduced pain and opioid use compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control, through
The primary and key secondary endpoints for both Phase 3 studies were identical.
Key secondary endpoints in order of evaluation were:
EPOCH1 was a randomized, placebo- and active-controlled, double-blind, Phase 3 clinical study evaluating the efficacy and safety
of locally administered HTX-011 at 60 mg compared to the standard dose of bupivacaine solution (50 mg) and placebo for post-operative pain control following bunionectomy surgery in 412 subjects. All primary
and key secondary endpoints were achieved:
Hernia Repair (Study 302/EPOCH2) Results
randomized, placebo- and active-controlled, double-blind, Phase 3 clinical study evaluating the efficacy and safety of locally administered HTX-011 at 300 mg compared to the standard dose of bupivacaine
solution (75 mg) and placebo for post-operative pain control following hernia repair surgery in 418 subjects. All primary and key secondary endpoints were achieved:
HTX-011 was well tolerated in both studies, with a safety profile comparable to placebo and bupivacaine solution. There were no drug-related serious adverse events or discontinuations due to drug-related adverse
events in HTX-011-treated patients, and there were fewer opioid-related adverse events in
HTX-011-treated patients.
HTX-011 is the first and only long-acting anesthetic designed to
address both postoperative pain and inflammation in a single administration at the surgical site. The unique synergy of bupivacaine and meloxicam in HTX-011 has consistently been shown to reduce pain over 72
hours significantly better than bupivacaine alone in multiple diverse surgical models. HTX-011 is administered as a single-dose application via needle-free syringe to directly coat the affected tissue within
the surgical site prior to suturing, which makes HTX-011 s route of administration faster, easier and potentially safer compared to numerous injections required with current local anesthetics.
Acute use of opioid pain medications for postoperative pain control is directly linked to over 2 million new persistent opioid users every year and
up to 440,000 new cases of Opioid Use Disorder annually, making postoperative opioid use an important contributor to the opioid epidemic in the United States. In addition, with more than a billion opioid pills taken home after surgery every year for
postoperative pain control, there is an enormous concern about diversion of these pills and a desperate need for effective non-opioid alternatives, said Eugene R. Viscusi, MD, Professor of Anesthesiology
and Chief of Pain Medicine in the Department of Anesthesiology at the Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, PA. The Phase 3 results with HTX-011 suggest it may be
a promising foundation in non-opioid multimodal pain management in a wide range of surgical procedures.
My family has endured unspeakable tragedy, losing our son, Tyler, to a heroin overdose that could have been prevented if he was not first exposed to
opioids following a routine elbow surgery. Physicians, patients and families need new, more effective pain management options to address postsurgical pain so that we can lessen the number of people that are exposed to harmful opioids, stopping
addiction before it starts, said Travis Bornstein, Founder Hope United.
With today s results,
HTX-011 is the only locally administered anesthetic to demonstrate superior pain relief and a reduction in opioid use as compared to not only placebo, but also the current standard-of-care, bupivacaine solution, in Phase 3 studies, said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. We look forward to submitting a New Drug Application for HTX-011 to the U.S. Food and Drug Administration in the second half of 2018. If approved, we believe that HTX-011 could have a significant impact on the opioid crisis by
reducing the use of opioids after surgery, while at the same time allowing patients to experience less pain.
Conference Call and Webcast
Heron Therapeutics will host a conference call and webcast today, March 19, 2018, 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 1369799 to join the conference call. A slide presentation accompanying today s press release and conference call may also be found on Heron s website at www.herontx.com under
the Investor Relations section. The conference call will also be available via webcast under the Investor Relations section of Heron s website. An archive of today s teleconference and webcast will be available on Heron s website for
60 days following the call.
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 prevention 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 three diverse surgical models: bunionectomy, hernia repair and abdominoplasty. HTX-011 is being investigated in ongoing Phase 2 studies in nerve block (breast augmentation) and total knee
arthroplasty. The Phase 3 program for HTX-011 is now complete and Heron today reported positive topline data from its pivotal bunionectomy and hernia repair studies.
HTX-011 was granted Fast Track Designation from the FDA in the fourth quarter of 2017. In the second half of 2018, Heron expects to file an NDA to the FDA for HTX-011.
About Heron Therapeutics, Inc.
Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments that 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
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: the timing of the HTX-011 NDA filing and review process, 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.
Investor Relations and Media Contact:
Senior VP, General Counsel, Business Development and Corporate Secretary
Heron Therapeutics, Inc.