May 9, 2019 PR-M05-19-NI-027
SAN DIEGO /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 they joined the National Academy of Medicine's (NAM) Action Collaborative on Countering the U.S. Opioid Epidemic (Action Collaborative).
The NAM's Action Collaborative is a one-of-a-kind, public-private partnership made up of more than 100 participants representing federal, state, and local governments, health systems, associations and provider groups, health education and accrediting institutions, pharmacies, payers, industry, nonprofits, and academia. The NAM's Action Collaborative is committed to developing, curating and disseminating multi-sector solutions designed to reduce opioid misuse and improve outcomes for individuals, families, and communities affected by the opioid crisis.
"Heron is pleased to join this important public-private partnership dedicated to finding solutions to combat the opioid epidemic," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics. "Through our membership, we hope to continue to increase awareness of the two key ways the surgical setting contributes to the opioid epidemic: exposing opioid naive patients to opioids; and placing up to a billion unused pills in medicine cabinets that are susceptible to diversion. Heron is proud to be the sole pharmaceutical industry representative currently involved in the NAM's Action Collaborative, bringing an important voice to discussing the role of innovative, non-opioid alternatives in combatting this crisis."
Heron's membership in the NAM's Action Collaborative builds upon Heron's ongoing commitment to reducing unnecessary exposure to opioids in the surgical setting and its pipeline of innovative, non-opioid postoperative pain therapies, including HTX-011, an investigational agent developed for application into the surgical site to reduce postoperative pain for 72 hours after surgery and the need for opioids.
"The opioid epidemic is one of the most devastating public health crises of the modern era, impacting individuals, families, and communities across the nation," said Victor J. Dzau, M.D., President of the National Academy of Medicine. "The complexity of this crisis requires sustained commitment from all stakeholders: health systems; federal and state governments; community organizations; provider groups; payers; industry; nonprofits; and academia. Reversing the opioid epidemic requires a multi-sectoral response, as no organization, agency, or sector can solve this problem on their own. NAM is privileged to lead this Action Collaborative, which will work to develop collective solutions and advance those with the most potential to reverse or stem the crisis. We are thrilled to see such a robust commitment from organizations across the country in joining with us to be part of the solution."
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 solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. 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 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. A Marketing Authorisation Application for HTX-011 was validated by the European Medicines Agency in March 2019 for review under the Centralised Procedure.
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; the timing of the commercial launch of HTX-011; the timing of the CHMP's 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.
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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.