In a phase 3b study, 75% of patients using HTX-011 were discharged without opioids following a total knee arthroplasty.
A new post-surgery drug that allows patients to forgo opioids could soon become available.
Heron Therapeutics, a commercial stage biotechnology company, announced positive topline results from their recent phase 3b clinical study examining HTX-011 to treat total knee arthroplasty (TKA).
The multi-center postoperative pain management study involved 51 patients who underwent total knee arthroplasty surgery and received the investigational agent with a scheduled postoperative regimen of generic, oral analgesics—acetaminophen and celecoxib.
The phase 3b study represents a follow-up study to the phase 2b study completed in 2018. The new study was designed to evaluate the decrease in pain and opioid use with HTX-011 when used with a regimen of generic oral analgesics.
HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.
The team found the treatment significantly reduced pain and opioid use compared to placebo through 72 hours. The investigators also found the medication significantly reduced pain compared to a bupivacaine solution, which is the current standard-of-care local anesthetic for postoperative pain control, using a last observation carried forward (LCOF) analysis.
It represents the only extended-release local anesthetic to demonstrate in phase 3 studies significantly reduced pain and opioid through 72 hours compared to a bupivacaine solution.
The investigators found that the mean pain scores remained in the mild range for 72 hours following surgery and 75% of patients were discharged without needing opioids.
The median consumption of opioids was 4-5 pills of oxycodone (22.5 morphine mg equivalents) through 72 hours.
The combination treatment was well tolerated throughout the study, with no deaths, serious adverse events, or premature discontinuations due to adverse events reported.
In the past, HTX-011 was studied as treatment for hernia repairs and bunionectomies.
In January, Heron reported 90% of patients receiving HTX-011 with a regimen of over-the-counter oral analgesics—acetaminophen and ibuprofen—did not require opioids through 72 hours post-hernia repair surgery.
In March, the company reported 77% of patients did not need opioids 72 hours post bunionectomy after receiving the same treatment regimen.
According to Barry Quart, President and Chief Executive Officer of Heron, more than 47,000 patients in the US died due to an opioid overdose in 2017.
Quart also said more than 1 billion pills are prescribed to patients following surgery, which when coupled with a lack of effective alternative regimens, contributes to the rising death toll.
"The results from recent studies in TKA, hernia repair and bunionectomy demonstrate that HTX-011 can effectively reduce pain and allow the majority of patients to be discharged without opioids," Quart said in a statement.
The US Food and Drug Administration (FDA) granted HTX-011 the Fast Track designation in 2017 and the Breakthrough Therapy designation in 2018.
Heron then submitted a New Drug Application (NDA) later in October 2018 and received a Priority Review designation in December.
The FDA sent a Complete Response Letter in April relating to chemistry, manufacturing and controls, and non-clinical information. However, no issues regarding clinical efficacy or safety were noted.
Heron resubmitted the NDA in September.