Non-opioid Pain Therapeutic Achieves More Than 100 Formulary Approvals

Baudax Bio’s meloxicam (Anjeso) injection for the treatment of adults with moderate-to-severe pain following surgery has received approvals at more than 100 formularies across the United States in less than one year on the market. The therapy is a 24-hour, intravenous COX-2 non-steroidal anti-inflammatory (NSAID).

“We continue to receive positive feedback from physicians, and we continue to see increases in new accounts, units sold, reorder rates, and usage patterns across the surgical setting,” Gerri Henwood, president and CEO of Baudax Bio, said in a press release.

The need for new, non-opioid formulations to address post-surgical pain is significant. Over a 20-year period ending in 2019, at least 500,000 people died from an overdose involving an opioid, according to CDC data.

Some who became addicted to opioids did so after being prescribed the pain medication following surgery. As this trajectory became known, more people became interested in non-opioid treatment for post-surgical pain. In fact, a 2017 Gallup poll found 78% of respondents were so concerned about opioid abuse that they said they would avoid pain medication entirely if possible.

The FDA approved Anjeso in February 2020 to be used alone or in combination with non-NSAID analgesics. The approval is supported by two phase 3 efficacy studies and one double-blind phase 3 safety study; overall, the New Drug Application included data for more than 1,400 patients in both phase 2 and 3 trials. The most common adverse events (AEs), which were reported in at least 2% of patients, were constipation, anemia, and gamma-glutamyl transferase.

In a recent study published this month in patients undergoing total knee arthroplasty, Anjeso reduced opioid use during the first 24 hours after surgery. Adverse events included nausea, vomiting, hypotension, pruritus, and constipation. In another October 2020 study published involving patients undergoing open or laparoscopic colorectal surgery, Anjeso was associated with 35% lower opioid use versus placebo and was generally well tolerated with treatment-emergent AEs including nausea and vomiting.

Baudax Bio launched Anjeso in June 2020. It was designed using the NanoCrystal platform, a technology developed by Alkermes Pharma Ireland that provides a faster onset of action of meloxicam compared with oral meloxicam.

Baudax Bio estimates that about 50 million surgical procedures a year require post-operative pain medication.

Meloxicam is also available as a tablet and an oral suspension to treat osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.