Recro Pharma Presents Clinical Data at American Pain Society 35th Annual Scientific Meeting
Poster Highlights Efficacy and Safety of IV Meloxicam in Subjects with Moderate to Severe Pain Following Hysterectomy
MALVERN, Pa., May 12, 2016 (GLOBE NEWSWIRE) — Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company developing non-opioid products for the treatment of serious acute pain, today announced a poster presentation at the American Pain Society’s 35th Annual Scientific Meeting, taking place May 11-14, 2016, in Austin, TX. The poster presentation highlights data from a clinical trial evaluating the efficacy and safety of intravenous (IV) meloxicam (N1539), in subjects with moderate to severe pain following open abdominal hysterectomy.
The poster will be available for viewing at the Experience Exchange section at the Austin Convention Center during the meeting. Company representatives will be available to discuss the poster during an author-attended session on Thursday, May 12, from 9:30 am – 11:00 am CDT.
“In the results reported at this year’s American Pain Society meeting, IV meloxicam was well tolerated and demonstrated its ability to provide a significant and sustained reduction in acute postoperative pain in patients following open abdominal hysterectomy,” said Stewart McCallum, MD, Recro Pharma’s Chief Medical Officer. “These results support Recro Pharma’s ongoing Phase III clinical program and underscore IV meloxicam’s potential as a promising non-opioid treatment option for patients with acute postoperative pain.”
These data are being presented in support of the Company’s lead product, IV meloxicam, a proprietary, preferential, long-acting COX-2 inhibitor that has successfully completed multiple Phase II clinical trials. Recro Pharma acquired the rights to IV meloxicam from Alkermes in April of 2015.
Details for the poster presentation at APS 2016 are as follows:
|Title:||An Evaluation of the Efficacy and Safety of N1539, a Novel Intravenous Formulation of NanoCrystal Meloxicam, in Subjects with Moderate to Severe Pain Following Hysterectomy|
|Summary:||The poster describes results from the randomized, double-blind portion of a multicenter study evaluating 460 female subjects, age 18-65 undergoing open abdominal hysterectomy.
This portion of the study evaluated the efficacy and safety of single doses of IV meloxicam (5-60 mg) compared with placebo and active control (morphine dosed at 0.15mg/kg, or
10-15 mg), in subjects with acute moderate to severe pain within 6 hours of last morphine dose, with a visual analog scale (VAS) score ≥45mm (0 to 100mm scale). The primary
efficacy endpoint was the summed Pain Intensity difference from Hour 0 to 24 (SPID24) and total Pain Relief from Hour 0 to 24 (TOTPAR24) after dosing. The study results
demonstrated that IV meloxicam was effective at treating moderate to severe pain following open abdominal hysterectomy. IV meloxicam met both co- primary endpoints at all
dose levels producing statistically significant differences in SPID24 and TOTPAR24 compared with placebo. IV meloxicam also produced statistically significantly better responses
in a number of secondary efficacy endpoints compared with placebo. IV meloxicam was safe and well tolerated with a low incidence of adverse events (AEs), serious adverse
events (SAEs), and discontinuations due to AE, and no deaths.
Downloadable copies of the posters can be accessed by visiting the “Investors” section of the Recro Pharma website and by clicking “Presentations”.
About Recro Pharma, Inc.
Recro Pharma is a revenue generating specialty pharmaceutical company developing non-opioid products for the treatment of serious acute pain. Recro Pharma is currently developing IV meloxicam, a proprietary, long-acting preferential COX-2 inhibitor for treatment of acute postoperative pain, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine, for the treatment of peri-procedural pain. Both compounds have successfully completed Phase II clinical trials. As Recro Pharma’s product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress, while maintaining analgesic effect.
Recro Pharma also owns and operates an 87,000 square foot, DEA-licensed facility that manufactures five commercial products and receives manufacturing revenues and royalties associated with the sales of these products. The campus includes an additional 10,000 square feet of administrative space and certain utility areas.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward looking statements reflect Recro Pharma’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to Recro Pharma or its management, are intended to identify such forward-looking statements. These forward looking statements are based on information available to Recro Pharma as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro Pharma’s performance to differ materially from those expressed in, or implied by, these forward looking statements. Recro Pharma assumes no obligation to update any such forward-looking statements. Factors that could cause Recro Pharma’s actual performance to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: results and timing of the clinical trials of injectable meloxicam and Dex-IN; the ability to obtain and maintain regulatory approval of injectable meloxicam and Dex-IN, and the labeling under any such approval; regulatory developments in the United States and foreign countries; the Company’s ability to raise future financing for continued development; the Company’s ability to pay its debt; the performance of third-party suppliers and manufacturers; the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; and the successful commercialization of injectable meloxicam and Dex-IN. In addition, the forward looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro Pharma’s business and future results included in Recro Pharma’s filings with the Securities and Exchange Commission at www.sec.gov. Recro Pharma assumes no obligation to update any such forward looking statements.
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Source: Recro Pharma, Inc.