Recro Pharma Inc. (NASDAQ: REPH) shares saw a handy gain on Monday after the company announced positive late-stage results. Its second of two Phase 3 clinical trials evaluating intravenous (IV) meloxicam for the treatment of acute postoperative pain saw the positive results. 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 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.
The study also achieved statistical significance for 10 of the secondary endpoints, including statistically significant differences in SPID12, time to perceptible pain relief, subjects with an equal to or greater than 30% improvement at 24 hours, number of times patients required rescue in the first 24 hours after randomization, as well as number of times rescued from 24 to 48 hours and several other pain relief metrics, compared to placebo.
The company plans to submit additional data from this Phase 3 clinical trial for presentation at a future scientific conference or in a journal publication.
Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research, commented:
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.
Shares of Recro Pharma were trading up over 18% at $9.21 on Monday, with a consensus analyst price target of $21.40 and a 52-week trading range of $5.59 to $12.50.