Upcoming AWS Coverage on Regeneron Pharmaceuticals Post-Earnings Results
LONDON, UK / ACCESSWIRE / November 29, 2016 / Active Wall St. blog coverage looks at the headline from Recro Pharma Inc. (NASDAQ: REPH) as the company announced on November 28th, 2016, positive results from its second of two Phase III clinical trials evaluating intravenous (IV) meloxicam for the treatment of acute postoperative pain. Register with us now for your free membership and blog access at:
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One of Recro Pharma's competitors within the Biotechnology space, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), announced on November 04, 2016, its financial results for the third quarter of 2016. AWS will be initiating a research report on Regeneron Pharma in the coming days.
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The Trial Results
Recro Pharma reported that the Phase III 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).
Recro Pharma noted that in this multicentre, randomized, double-blind, placebo-controlled clinical trial, 219 patients were enrolled and randomly assigned to receive a postoperative regimen of IV meloxicam or placebo in a 1:1 ratio, once every 24 hours. The IV meloxicam treatment arm demonstrated a statistically significant reduction in SPID24 compared to the placebo arm. 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 ≥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 stated that 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. The most common adverse events (AEs) were nausea, headache, vomiting, and dizziness. 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.
"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," said Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research.
"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," said Gerri Henwood, Recro Pharma's President and Chief Executive Officer, "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."
Recro plans to submit additional data from this Phase III clinical trial for presentation at a future scientific conference or in a journal publication. Recro Pharma stated that enrolment in the remaining, on-going safety study is expected to be complete by the end of the first quarter or early Q2 2017, with an NDA filing expected to follow in summer 2017.
About IV/IM Meloxicam
Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses anti-inflammatory, analgesic, and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. Meloxicam has been marketed by Boehringer Ingelheim Pharmaceuticals, Inc. since the 1990's as an oral agent, Mobic®. IV/IM meloxicam was designed using NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. Recro acquired IV/IM meloxicam from Alkermes in April 2015.
Stock Performance
At the close of trading session on November 28, 2016, following the announcement, Recro Pharma's stock price surged 19.85% to end the day at $9.30. A total volume of 4.70 million shares were exchanged during the session, which was above the 3-month average volume of 62.65 thousand shares. The company's share price has gained 31.17% in the past one month and 3.33% on an YTD basis. The stock currently has a market cap of $113.18 million.
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