FDA Approves Opioid Treatment Option

The U.S. Food and Drug Administration has approved the use of an intravenous form of the pain reliever meloxicam (Anjeso, Baudax Bio) for the relief of moderate to severe pain.

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) currently available in tablet form as Mobic by Boehringer Ingelheim. It is approved for the relief of pain associated with osteoarthritis and rheumatoid arthritis in adults, and in children two years and older who have juvenile rheumatoid arthritis.

Now, it can be administered as a once a day, 24-hour intravenous NSAID treatment for patients with moderate to severe pain.

The active ingredient in meloxicam is a long-acting, preferential COX-2 inhibitor with analgesic, anti-inflammatory and antipyretic activities, which inhibits COX-2 thereby reducing prostaglandin biosynthesis.

“The approval of Anjeso marks a major advancement in the treatment landscape for managing moderate to severe pain. With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm," said Gerri Henwood, president and chief executive officer of Baudax Bio, in a press statement.

The company cited the success several mid to late stage clinical trials on Anjeso, plus a recent phase three safety trial that showed the treatment was well tolerated as an option to opioids.

“While traditional opioid medications have proven effective at providing pain relief, the associated adverse side effects, including sedation and respiratory depression, have driven physicians to employ a multi-modal approach to treating post-operative pain. With 24-hour, durable pain relief and a safety profile comparable to placebo, Anjeso has the potential to serve as a meaningfully differentiated analgesic alternative,” said the University of Miami's Keith Candiotti, M.D., in a written statement.

The Anjeso approval is supported by two phase three efficacy studies, one double-blind, placebo-controlled phase three safety study and four phase two clinical studies. A randomized multicenter, double-blind, placebo-controlled phase three study of 379 orthopedic surgery patients showed that patients receiving once-daily intravenous meloxicam 30 mg for seven days required fewer opioids. Total opioid consumption (36.8 mg versus 50.3 mg IV morphine equivalent dose) and opioid consumption from zero to 24 hours, 24‒48 hours, zero to 48 hours, and zero to 72 hours were statistically significantly lower in the meloxicam treatment group. The side effects were reported as mild to moderate and affected 65 percent of patients.

The most common adverse reactions reported in at least 2 percent of patients treated with Anjeso and at a greater frequency than placebo included: constipation, gamma-glutamyl transferase increased and anemia.