MALVERN, PA — Recro Pharma, Inc. (NASDAQ: REPH), a revenue-generating specialty pharmaceutical company focused on therapeutics for hospitals and other acute care settings, today announced the publication of new intravenous (IV) meloxicam data. The article, titled “Meloxicam intravenous for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects,” was published online in Regional Anesthesia & Pain Medicine. A New Drug Application (NDA) for IV meloxicam is currently under review by the U.S. Food and Drug Administration (FDA) and the Company is currently awaiting its assigned PDUFA goal date of March 24, 2019.
“The pooled safety data from the Phase II/III clinical program shows that IV meloxicam was generally well-tolerated in patients with moderate to severe postoperative pain as indicated by a low incidence of treatment-emergent adverse events (TEAEs) that was comparable with placebo,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer of Recro Pharma. “Given the ongoing opioid epidemic, many expert healthcare organizations now recommend clinical strategies that utilize multimodal analgesia, which can include non-steroidal anti-inflammatory drugs (NSAIDs), to help reduce excessive opioid use. The opioid-reducing effects published today continue to support our belief that IV meloxicam has the potential to help physicians reduce the use of rescue opioids in the postoperative setting.”
The published data describe the pooled safety across a total of seven clinical studies (three Phase III and four Phase II), where IV meloxicam (5-15mg, 30mg or 60 mg) was evaluated in patients following several types of surgeries, including dental impaction surgery, open abdominal hysterectomy, abdominal laparoscopic surgery, bunionectomy, and abdominoplasty, among others. In this pooled analysis, IV meloxicam was generally well-tolerated, with the incidence of TEAEs occurring in a lower percentage of IV meloxicam-treated patients than in placebo-treated patients (47% versus 57%, respectively). The most commonly reported TEAEs across all treatment groups were nausea, headache, vomiting and dizziness. Notably, TEAE incidence was generally similar between the overall study populations and older patients (>65 years) with impaired renal function. There were no drug-related deaths for patients treated with IV meloxicam. Serious adverse events occurred at a lower frequency in the 30mg IV meloxicam treated group compared to the placebo group.
In the Phase II/III postsurgical study program where opioid rescue medication consumption was monitored, IV meloxicam was often associated with prolonged time to first rescue medication use and reduced rescue medication requirements. In the Phase III, randomized, double-blind, placebo-controlled trial evaluating IV meloxicam following major surgery (NCT02720692), IV meloxicam was associated with reduced opioid consumption. Mean opioid consumption in the overall population was significantly less in the IV meloxicam group compared with the placebo group in the hour 0‒24, hour 0‒48 and hour 0‒72 intervals (p<0.05). Decreased opioid use among patients treated with IV meloxicam compared with placebo-treated subjects was observed across all subgroups (i.e., surgery type, risk group and demographic characteristics). In the IV meloxicam treatment group, decreased opioid use corresponded to fewer TEAEs commonly associated with opioid administration during the initial postoperative period. Additionally, in both the Phase II dental impaction and hysterectomy studies, the percentage of subjects using opioid medication after surgery was lower in the IV meloxicam (30mg) group compared with the placebo group (37% versus 95% and 58% versus 93%, respectively). Although a statistical evaluation was not conducted across the pooled studies, a trend indicating a decrease in adverse events commonly associated with opioid administration such as nausea, vomiting, constipation and pruritus was observed.
The full publication can be accessed here.
Source: Recro Pharma, Inc., 490 Lapp Road, Malvern PA 19355
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