RCT (n=343)
double-blind
randomized
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“From a clinical perspective, the published LTG-001 results in moderate-to-severe pain following abdominoplasty represent an important development in the treatment of acute pain, with the highest analgesic effect reported in a published industry-sponsored abdominoplasty trial. While opioids have historically been among the most effective options for treating acute pain, their associated risks underscore the importance of continued research into non-opioid approaches. These published results of LTG-001 add to the growing body of evidence supporting the investigation of novel, non-opioid mechanisms for pain management at a time when there remains significant focus on addressing the public health impact of opioid use.”
“This publication in the New England Journal of Medicine is a significant milestone for LTG-001. 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.”
“We first reported a 'slow' sodium channel, responsible for hyperactivity in human pain-signaling neurons, in 1987. That channel was subsequently cloned and then named Nav1.8. Its essential role in pain signaling within peripheral nerve -- and lack of a role in the central nervous system -- made it a focus in attempts to develop non-addictive pain medications.”
Randomized trial evaluates analgesic effects of Nav1.8 inhibitor for acute pain, suggesting potential therapeutic benefits.
METHODS: We conducted a phase 2b, double-blind, randomized, placebo-controlled trial to evaluate LTG-001, a selective Na RESULTS: A total of 343 patients underwent randomization. The least-squares mean SPID48 was 161.05 (95% confidence interval [CI], 142.93 to 179.16) in the low-dose group, 185.30 (95% CI, 167.26 to 203.34) in the high-dose group, 164.08 (95% CI, 146.02 to 182.14) in the hydrocodone bitartrate-acetaminophen group, and 123.22 (95% CI, 105.23 to 141.21) in the placebo group. The least-squares mean difference in the SPID48 between LTG-001 and placebo was significant for each dose (low dose: 37.82 [P = 0.003]; high dose: 62.08 [P<0.001]), and that between hydrocodone bitartrate-acetaminophen and placebo was 40.86. High-dose LTG-001, but not low-dose LTG-001, was associated with significantly lower opioid use than placebo (11.00 MME vs. 18.35 MME, P = 0.01), as well as a significantly higher percentage of patients who received no opioid rescue medication (52% vs. 22%, P<0.001). High-dose LTG-001 was associated with a higher incidence of pyrexia than placebo (7% vs. 2%) and a higher incidence of presyncope (6% vs. 1%). CONCLUSIONS: LTG-001 led to significantly greater reductions in pain scores than placebo over the course of 48 hours after abdominoplasty. (Funded by Latigo Biotherapeutics; LTG-001-010 ClinicalTrials.gov number, NCT07102459.).
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Singla et al. (2026) conducted an RCT in Acute Pain (n=343). LTG-001 vs. Placebo and hydrocodone bitartrate-acetaminophen was evaluated on SPID48 (Sum of Pain Intensity Differences over 48 hours) (MD 62.08, p=<0.001).
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