Novel Nav1.8 inhibitor reduces pain following abdominoplasty

For patients undergoing abdominoplasty, treatment with the investigational Na_v1.8 inhibitor helps relieve postoperative pain, as shown in a phase IIb trial.

The trial included 343 patients with moderate-to-severe pain following abdominoplasty. These patients were randomly assigned to receive a 300-mg loading dose of LTG-001, followed by 150 mg every 12 hours (low-dose group); a 450-mg loading dose of LTG-001, followed by 300 mg every 12 hours (high-dose group); hydrocodone bitartrate–acetaminophen (5 mg of hydrocodone bitartrate and 325 mg of acetaminophen) every 6 hours; or placebo every 6 hours. Treatment was administered orally over a 48-hour period.

The primary endpoint was the time-weighted sum of the pain-intensity difference (SPID) over the 48-hour treatment period (SPID48), assessed using the Numeric Pain Rating Scale, with higher SPID48 values indicating greater pain reduction. Secondary endpoints included the amount of opioid rescue medication consumed in morphine milligram equivalents (MME) and no receipt of opioid rescue medication.

The mean SPID48 was 161.05 in the low-dose group, 185.30 in the high-dose group, 164.08 in the hydrocodone bitartrate–acetaminophen group, and 123.22 in the placebo group. The mean difference in the SPID48 was significant between LTG-001 and placebo (p=0.003 for the low dose and p<0.001 for the high dose).

Compared with patients in the placebo group, those in the high-dose LTG-001 group had significantly lower opioid use (11 vs 18.35 MME; p=0.01) and were more likely to receive no opioid rescue medication (52 percent vs 22 percent; p<0.001).

In terms of safety, high-dose LTG-001 was associated with a higher frequency of pyrexia (7 percent vs 2 percent) and presyncope (6 percent vs 1 percent) compared with placebo.