- Recro Pharma, a Pennsylvania-based specialty pharma, on Monday reiterated that it expects to file an application for approval of its non-opioid pain drug with the Food and Drug Administration sometime during summer 2017.
- The company confirmed its filing plans after a second Phase 3 trial of intravenous meloxicam hit its primary endpoint, reducing post-operative acute pain compared to placebo in patients following abdominoplasty surgery.
- Another late-stage study, testing meloxicam in patients following bunionectomy, read out positively this past July. A safety study is ongoing and is expected to wrap up by the end of the first quarter or early in the second quarter of next year.
Meloxicam is an older non-steroidal anti-inflammatory drug, first developed by Boehringer Ingelheim and approved by the FDA for treatment of osteoarthritis in 2000. Boehringer's market exclusivity on meloxicam lapsed in 2006, allowing generic copies onto the market in the U.S.
Recro acquired rights to the intravenous form of meloxicam in a 2015 deal with Alkermes, paying $50 million upfront for licensing and ownership of a manufacturing facility in Gainesville, Georgia.
In the most recent trial, treatment with meloxicam led to a statistically significant reduction in a measurement of pain known as summed pain intensity difference over the first 24 hours post-operation. The drug's safety profile compared favorably to placebo, according to the company.
Recro appears to be positioning IV meloxicam as an alternative solution to opioid-based analgesics for pain management. According to a year-end regulatory filing, Recro anticipates IV meloxicam, if approved, will compete mostly with those drugs, such as opioids marketed by Purdue Pharma, Endo Pharmaceuticals and Mallinckrodt Pharmaceuticals.
In order to help fund ongoing development expenses, Recro sold nearly 2 million shares in a public offering in August, raising $13.4 million in net proceeds. As of September 30, the company had nearly $25 million in cash and equivalents on its balance sheet.