Stock Monitor: Advaxis Post Earnings Reporting
LONDON, UK / ACCESSWIRE / March 29, 2018 / Active-Investors.com has just released a free research report on Recro Pharma, Inc. (NASDAQ: REPH). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/'symbol=REPH as the Company's latest news hit the wire. On March 27, 2018, the Company, which is a specialty pharmaceutical organization that focuses on therapeutics for hospitals and other acute care settings, announced the publication of its Phase-III clinical data for intravenous (IV) meloxicam for the treatment of post-bunionectomy surgery pain. Register today and get access to over 1000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Recro Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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Recro Pharma published an online article titled: "Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-Severe Pain Following Bunionectomy", in the Clinical Journal of Pain.
About IV/IM Meloxicam
Meloxicam is a long-acting, preferential COX-2 inhibitor. It has analgesic, anti-inflammatory, and antipyretic activities, related to the inhibition of cyclooxygenase (COX) and a subsequent reduction in prostaglandin biosynthesis. The drug leverages the novel NanoCrystal® platform technology, which enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Ltd ("APIL").
Phase-III Trial - Design and Results
Design
The Phase-III Trial was a multi-center, randomized, double blind, placebo-controlled trial (n=201), which was specifically designed to assess the efficacy and safety of IV meloxicam 30mg for the management of moderate-to-severe pain after the bunionectomy surgery.
Results
- The primary efficacy endpoint for the Phase-III Trial was Summed Pain Intensity Difference (SPID) over 48 hours (SPID48). IV meloxicam 30mg demonstrated a statistically significant difference reduction in SPID48 (p=0.0034), as well as statistically significant reductions in SPID values at other times and intervals (SPID6, SPID12, SPID24, SPID24-48), among other key secondary endpoints.
- Besides, an opioid-sparing effect was also noted in IV meloxicam 30mg, indicated by a longer time to first use of rescue (p=0.0076), a lower number of subjects using rescue (p<0.001), and the lower mean number of per-subject rescue doses (p<0.05).
- The Trial also proved that IV meloxicam 30mg was well tolerated. No associated serious adverse events (SAEs) or withdrawals due to adverse events (AEs) were noted in this trial. Moreover, the treatment-emergent adverse events observed in the IV meloxicam 30mg group were mild or moderate in intensity, with the incidence and intensity similar to the placebo group.
IV Meloxicam Has Potential to Fill Significant Medical Need
Currently, there is an urgent, unmet medical need for patients and physicians for the management of moderate-to-severe post-bunionectomy surgery pain. The data from the Phase-III trial proves that IV meloxicam has the potential to provide rapid and sustained pain relief from bunionectomy surgery. The Trial validates that IV meloxicam has a favorable safety and tolerability profile, with a notable opioid-sparing effect. The New Drug Application (NDA) for IV meloxicam is already under review with the US Food and Drug Administration (FDA), which has a target Prescription Drug User Fee Act (PDUFA) date of May 26, 2018.
Stewart McCallum, M.D., Chief Medical Officer at Recro Pharma, shared that if IV meloxicam gets approved, it would be the first 24-hour duration, non-opioid, IV analgesic for managing moderate-to-severe pain.
Stock Performance Snapshot
March 28, 2018 - At Wednesday's closing bell, Recro Pharma's stock fell 1.20%, ending the trading session at $10.73.
Volume traded for the day: 161.59 thousand shares.
Stock performance in the last month - up 20.29%; previous three-month period - up 11.77%; past twelve-month period - up 36.17%; and year-to-date - up 16.00%
After yesterday's close, Recro Pharma's market cap was at $210.52 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.7% at the end of the session.
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