High-dose LTG-001 significantly reduced pain scores over 48 hours after abdominoplasty compared to placebo, with a mean difference in SPID48 of 62.08 (P<0.001).
RCT (n=343)
double-blind
randomized
Mean Difference: 62.08
Absolute Event Rate: 185.3% vs 123.22%
p-value: p=<0.001
BACKGROUND: Na 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.).
“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.”
Singla et al. (Wed,) conducted a 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). High-dose LTG-001 significantly reduced pain scores over 48 hours after abdominoplasty compared to placebo, with a mean difference in SPID48 of 62.08 (P<0.001).