Opioid Alternative Tx for Surgical Site Granted Fast Track Status
Heron Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation to HTX-011, an investigational agent to reduce postoperative pain and the need for opioid analgesics for 72 hours.
HTX-011 is the first and only long-acting, extended-release formulation of the anesthetic bupivacaine. Phase 2 clinical studies have found that HTX-011, which leverages meloxicam to potentiate the local anesthetic activity over 72 hours, significantly reduced the need for opioids following surgery.
In bunionectomy, HTX-011 (60mg) was found to significantly reduce pain through 72 hours compared to placebo (P=0.0003) and bupivacaine (P=0.0166). Additionally, significantly more patients treated with HTX-011 were opioid-free through 72 hours vs placebo (P=0.0106). In hernia repair, significantly better pain reduction was seen for HTX-011 (300mg) compared to placebo (P=0.0045) and bupivacaine (P=0.0427), with significantly more opioid-free patients through 72 hours (P=0.0001 and P=0.0108, respectively).
Current Phase 3 studies are based on results from these Phase 2 trials in bunionectomy and hernia repair. "We expect to report top-line results from our pivotal Phase 3 studies in the first half of 2018 and then file for FDA review in the second half of 2018," said Barry D. Quart, PharmD, CEO of Heron. "Fast Track designation may allow us to expedite our commercial launch of HTX-011."
HTX-011 uses Heron's proprietary Biochronomer drug delivery technology.
For more information visit Herontx.com.