HTX-011, which utilizes our proprietary Biochronomer® drug delivery technology, is under investigation in Phase 3 clinical studies as a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risks of harmful side effects, abuse, and addiction.
HTX-011 is the first long-acting anesthetic that is designed to address both post-operative pain and accompanying inflammation by combining the local anesthetic bupivacaine and the anti-inflammatory meloxicam in a single administration. Targeting both pain and inflammation has allowed HTX-011 to demonstrate an advantage over current standard of care in multiple surgical models-bunionectomy, hernia repair and abdominoplasty (tummy tuck)-in Phase 2 studies.
Across these studies, HTX-011 demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery. These results confirm the broad utility of HTX-011 with successful use across a wide range of surgeries, from small to very large incisions. In addition, data from these studies established, for the first time, the synergy between the local anesthetic bupivacaine and the anti-inflammatory meloxicam in HTX-011, which Heron believes is an important advancement for management of post-operative pain.
Following a successful End-of-Phase 2 meeting with the US Food and Drug Administration (FDA), general agreement was reached on Heron’s Phase 3 program, which includes 2 pivotal Phase 3 efficacy studies in bunionectomy and hernia repair and an approximately 200-patient Phase 3 safety and pharmacokinetics study to meet the target patient numbers established by the FDA and to provide further evidence of the broad utility of HTX-011 across multiple surgical models. The FDA noted that, beyond the agreed-upon Phase 3 studies, no additional clinical work is needed to meet the “Combination Rule” for fixed-dose combination products. The Phase 3 program is designed to achieve a broad indication for the reduction in postoperative pain for 72 hours and reduce the need for opioid analgesic medications following surgery.
Recently, Heron initiated patient enrollment in its Phase 3 program and anticipates completing the Phase 3 program in the first half of 2018. Heron expects to file an NDA for HTX-011 in 2018.