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news.Recro Pharma has unveiled positive results from its second of two Phase III clinical trials assessing intravenous (IV) meloxicam for the treatment of acute postoperative pain.
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In this trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 24 hours (SPID24), compared to placebo, in patients following abdominoplasty surgery.
With the positive data from this study, the Company believes this completes the efficacy program for the IV meloxicam New Drug Application (NDA).
In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of IV meloxicam (30mg bolus injection) or placebo in a 1:1 ratio, once every 24 hours. The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID24 (p=0.0145) compared to the placebo arm.
The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12 (p=0.0434), time to perceptible pain relief (p=0.0050), subjects with ≥30% improvement at 24 hours (p=0.0178), number of times patients required rescue in the first 24 hours after randomization (p=0.0275), as well as number of times rescued from 24 to 48 hours (p=0.0009), and several other pain relief metrics, compared to placebo.
The safety results demonstrated that IV meloxicam was well tolerated with no difference in serious adverse events (SAEs) related to bleeding for IV meloxicam treated patients versus placebo (1 each). There were two additional SAEs observed in the placebo group.
The most common (≥2% in the IV meloxicam group) adverse events (AEs) were nausea, headache, vomiting, and dizziness. The incidence of these events was lower than those observed in the placebo group. The majority of AEs were mild in nature and one patient in the placebo group discontinued treatment due to an adverse event of post-procedural bleeding.
There were no meaningful differences between treatment groups in vital signs, ECGs or clinical lab assessments.
Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research, said: “The data from this trial demonstrated that IV meloxicam achieved a statistically significant difference in SPID24 pain relief following abdominoplasty surgery, a favorable safety and tolerability profile, and impressive impact on the number of times patients required rescue throughout the 0-24 and 24-48 hour periods, as well as the percent of subjects with ≥30% improvement at 24 hours.
“These data are important because they show that, if approved, IV meloxicam has the potential to be a new, non-opioid alternative for patients with moderate-to-severe pain following soft tissue surgery.”
Recro Pharma president and CEO Gerri Henwood said: “The positive outcome from this second pivotal trial continues to demonstrate the efficacy of IV meloxicam in the acute postoperative setting, while reinforcing the favorable efficacy and safety profile observed in five prior studies.
“Given the urgent need for non-opioid pain relief alternatives, we believe the data from this trial, together with the positive data from our previously reported pivotal Phase III trial in post-surgical bunionectomy patients, completes the efficacy platform for an NDA for IV meloxicam as a new, non-opioid analgesic option for acute moderate-to-severe postoperative pain.
"Enrollment in the remaining, ongoing safety study is expected to be complete by the end of the first quarter or early second quarter 2017, with an NDA filing expected to follow in summer 2017.”
The secondary endpoints of: SPID6, time to first rescue, number of subjects rescued 0-24 hours, number of subjects rescued 0-48 hours, time to meaningful pain relief, percent of subjects ≥30% improved at 6 hours, percent of subjects ≥50% improved at 6 or 24 hours, and Patient Global Assessment of pain control at 24 hours were not significantly different between treatment groups.
Recro plans to submit additional data from this Phase III clinical trial for presentation at a future scientific conference or in a journal publication.