Recro Pharma Inc. (NASDAQ: REPH) announced that it has hit success in a Phase 3 study of the intravenous version of its painkiller drug called Meloxicam. The company has been testing the drug in a pair of late-stage trials and said that the results from the second Phase 3 study that is still ongoing will be released by the end of 4Q2016 and after that the process to seek commercialization approval will begin.
Recro Pharma Inc. (NASDAQ: REPH) has been working to develop intravenous version of Meloxicam and rolled out a pair of Phase 3 studies of intravenous Meloxicam. An intravenous version of Meloxicam should increase the sales of the drug.
Recro’s Meloxicam is being developed as a treatment for acute pain in patients who have undergone a surgery to remove or realign the soft tissues as well as bones in the joint of their big toe.
Meloxicam is a non-opioid drug, which means that it is not associated with the adverse side effects known for opioid-based drugs. The side effects of opioid drugs include constipation, addiction and breathing problem.
About the successful trial by Recro Pharma Inc. (NASDAQ: REPH)
In the first Phase 3 trial of Meloxicam, Recro Pharma Inc. (NASDAQ: REPH) said the drug met its primary endpoint, which was statistically significant reduction in the intensity of pain compared with a placebo in the first 48 hours of treatment.
Besides meeting the primary goal of the first Phase 3 study, the drug also met 15 out of the 19 secondary endpoints that the study also evaluated.
Recro said that Meloxicam was well-tolerated in the patients who received it and it didn’t show any serious adverse events that would have required discontinuation of the study.
What next with Meloxicam?
The other portion of the Phase 3 trial of Meloxicam is still ongoing and Recro Pharma Inc. (NASDAQ:REPH) said it the results could be ready to report by the end of the next quarter.
Recro Pharma Inc. (NASDAQ:REPH) has said that it is on track to seek marketing clearance for the intravenous version of Meloxicam. The management has tentatively set mid-summer 2017 as the time for submitting request for marketing approval for intravenous Meloxicam.