- Announced Positive Data from Pivotal Phase III Trial of IV Meloxicam Following Bunionectomy Surgery. Recro reported positive data from the first of two pivotal efficacy Phase III clinical trials of IV meloxicam. In this multicenter, randomized, double-blind, placebo-controlled trial, IV meloxicam achieved its primary endpoint of a statistically significant reduction in Summed Pain Intensity Difference (SPID) over 48 hours (SPID48) versus placebo. The study also achieved 15 of 19 secondary endpoints. Since enrollment is now completed, Recro remains on track to report top-line data from its second pivotal Phase III trial of IV meloxicam following mini abdominoplasty surgery by the end of 2016.
- Strengthened Balance Sheet with Underwritten Common Stock Offering. In August, Recro completed an underwritten public offering of 1,986,666 shares of its common stock at a price of $7.50 per share, from which the Company raised a total of approximately $13.4 million in net proceeds.
- Strong Gainesville Manufacturing Performance. Recro's manufacturing business continued to perform well with revenues of $52 million for the nine months ended September 30, 2016, generating positive cash flow for the Company. We now anticipate 2016 full year revenue from our manufacturing business to exceed approximately $60 million (our most recent guidance had been for revenues of approximately $55-60 million), reflecting the benefit of a positive one-time revenue adjustment occurring in the third quarter of 2016. For 2017, we currently expect revenues of approximately $55 to $60 million, consistent with our expectations of the manufacturing business recurring revenue level.
Announced Positive Phase III Results from Pivotal Trial of IV Meloxicam Following Bunionectomy Surgery Pivotal Phase III Trial of IV Meloxicam Following Mini Abdominoplasty Surgery Ongoing; Top-line Data Expected by Year End MALVERN, Pa., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Recro Pharma, Inc (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings, currently developing non-opioid products for the treatment of serious acute pain, today reported financial results for the third quarter ended September 30, 2016. "During the third quarter, we made significant progress advancing our lead candidate, IV meloxicam, with positive top-line data from the first of two pivotal Phase III efficacy trials, and we remain on track to report top-line data from the second pivotal trial by year end," said Gerri Henwood, President and Chief Executive Officer of Recro Pharma. "With the acute pain space currently dominated by opioids, which can cause addiction and other serious side effects, there exists an urgent medical need for non-opioid options that provide patients with rapid and sustained pain relief. We look forward to sharing future clinical updates as we work toward a possible NDA filing for IV meloxicam in mid-summer 2017." Third Quarter 2016 and Recent Highlights