Heron Announces European Medicines Agency Validation of Marketing Authorisation Application for HTX-011 for Postoperative Pain Management
HTX-011 is the first and only dual-acting local anesthetic. HTX-011's novel mechanism of action combines bupivacaine with low-dose meloxicam to overcome the challenges of the inflammatory process at the surgical site. HTX-011 has significantly reduced severe pain and the need for opioids better than standard-of-care bupivacaine solution over 72 hours following surgery.
The MAA for HTX-011 is supported by data from 7 completed Phase 2 and Phase 3 studies in more than 1,000 subjects across 5 different surgical models, which are also included in the New Drug Application (NDA) Heron submitted to the
HTX-011 is the only non-opioid pain medication to have been granted Fast Track designation, Breakthrough Therapy designation and Priority Review designation by the
"Improved post-operative pain management remains as much an unmet need in
"We are pleased that our MAA for HTX-011 was validated by the EMA," said
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 FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. The
For more information, visit www.herontx.com.
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
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