New Non-Opioid Analgesic Works Better Than Vicodin
/By Crystal Lindell
An experimental non-opioid pain medication appears to outperform a low dose of Vicodin for patients who just had tummy-tuck surgery.
Latigo Biotherapeutics recently published results from its Phase 2 clinical trial in The New England Journal of Medicine, looking at the effectiveness of their new analgesic, which goes by the name LTG-001.
Like other new non-opioid analgesics, LTG-001 works differently than opioids because it blocks pain signals in the body’s peripheral nervous system before they reach the brain. Opioids act on nerve receptors in the brain, where they can slow down breathing and have a “euphoric” effect at high doses.
In the clinical trial, 343 patients with moderate-to-severe post-operative pain after abdominoplasty surgery were randomly assigned to four groups. One group received low-dose LTG-001; another took high-dose LTG-001; a third took tablets of 5 mg hydrocodone and 325 mg acetaminophen (Vicodin); and the fourth group received a placebo.
The LTG-001 doses were given orally every 12 hours, while the Vicodin tablets were taken every six hours, for a daily dose of 20 MMEs (morphine milligram equivalents). Patients also had the option to request oxycodone if their pain was getting too severe.
When researchers asked patients about their pain levels, they found that the high-dose LTG-001 had a 50% greater analgesic effect than Vicodin. “Meaningful pain relief” was also achieved faster with high-dose LTG-001 than with Vicodin (52 minutes vs. 83 minutes).
But many in the high dose LTG-001 group were not able to stay “opioid free.” In a press release, Latigo highlighted the fact that over half (52%) of the patients taking LTG-001 didn’t need the oxycodone “rescue” medication.
Another way to look at that statistic is that the other 48% of patients did not have pain that was well controlled and wound up using opioids anyway. On average, patients in the high dose LTG-001 group still needed 11 MME of oxycodone for pain relief.
Company officials said the study was “an important milestone for Latigo.”
“The publication of these findings adds to the growing scientific understanding of non-opioid approaches to pain management and comes at a time when there is broad recognition of the need for additional treatment options in the context of the ongoing opioid crisis,” Neil Singla, MD, Chief Medical Officer of Latigo, said in a statement.
Based on discussions with the FDA, Latigo believes the study may serve as one of the well-controlled trials needed to demonstrate the efficacy of LTG-001 to support its approval as a treatment of moderate to severe acute pain, including postoperative pain.
The company’s next step is to initiate a placebo-controlled Phase 3 trial in participants undergoing bunionectomy and an open-label Phase 3 safety trial. Latigo is also investigating LTG-001 as a pain reliever after wisdom tooth removal.
Last year the FDA approved a similar non-opioid analgesic, Journavx. Although it is only approved for moderate to severe acute pain, it didn’t take long for Jourvanx to be used off label for chronic pain. A recent analysis of prescription data found that Jourvanx is prescribed about 33% of the time for chronic pain. In fact, it’s prescribed more often for chronic pain than opioids are.
