Heron Therapeutics Granted FDA Fast Track Designation for HTX-011 to Reduce Postoperative Pain and the Need for Opioid Analgesics for 72 Hours
10/26/2017
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- First Opioid Alternative for Local Administration Into the Surgical Site Granted Fast Track Designation -
- Phase 3 Studies for HTX-011 Ongoing; NDA Filing Planned for 2018 -
“Fast Track designation of HTX-011 is an important milestone in ongoing
efforts to get ahead of the opioid crisis in America with preventative
measures,” said
HTX-011 is the first and only long-acting, extended-release formulation of the anesthetic bupivacaine designed to address both postoperative pain and inflammation in a single administration at the surgical site. HTX-011 leverages meloxicam in our proprietary polymer formulation to potentiate the local anesthetic activity of bupivacaine over 72 hours. In Phase 2 clinical studies, HTX-011 has consistently demonstrated superiority over both placebo and bupivacaine, the current standard-of-care, in all surgical models evaluated and significantly reduced the need for opioids following surgery. The ongoing Phase 3 studies were designed using the following Phase 2 results for HTX-011:
- Bunionectomy: HTX-011 60 mg
reduced pain through 72 hours significantly better than placebo
(p=0.0003) and bupivacaine 50 mg (p=0.0166)
- HTX-011 significantly increased the proportion of patients that were opioid-free through 72 hours after surgery, as compared to placebo (p=0.0106)
- Hernia Repair: HTX-011 300
mg reduced pain through 72 hours significantly better than placebo
(p=0.0045) and bupivacaine 75 mg (p=0.0427)
- HTX-011 significantly increased the proportion of patients that were opioid-free through 72 hours after surgery, as compared to placebo (p=0.0001) and bupivacaine 75 mg (p=0.0108)
“We are very pleased to receive Fast Track designation for HTX-011 and
look forward to working closely with the
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. The Phase 2 development program for HTX-011 was designed to target the many patients undergoing a wide range of surgeries who experience significant postoperative pain. Heron has recently initiated the HTX-011 Phase 3 program and expects to file an NDA in 2018.
About
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 completion and results of the Phase 3
studies for HTX-011; the timing of the HTX-011 NDA filing and review;
the timing of the HTX-011 commercial launch; and other risks and
uncertainties identified in the Company’s filings with the
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Source:
Heron Therapeutics, Inc.
David L. Szekeres, 858-251-4447
Senior
VP, General Counsel, Business Development and Corporate Secretary
dszekeres@herontx.com