Novel Drug for Pain Management Granted FDA Approval

Officials with the FDA have approved Baudax Bio’s meloxicam injection (Anjeso) for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics, according to the company.

The new drug is a nonopioid therapeutic option for patients experiencing moderate to severe pain. In a press release, Gerri Henwood, President and CEO, Baudax Bio said meloxicam injection will be available to physicians and patients in 2020 by late April or early May.

Meloxicam injection will be administered as a once-a-day intravenous (IV) bolus push. The drug is the only available 24-hour, intravenous (IV) COX-2 preferential nonsteroidal anti-inflammatory (NSAID) and offers once-daily dosing, according to Baudax Bio. The active ingredient meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities that are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2), and subsequent reduction in prostaglandin biosynthesis.

According to Dr. Keith Candiotti chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami, the approval of meloxicam injection marks an important achievement for the medical community in regards to the unmet need for nonopioid pain management options.

“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 Candiotti, in a prepared statement.

The FDA’s approval of meloxicam injection is supported by a pair of phase III efficacy studies, and 1 double-blind, placebo-controlled Phase III safety study. The results from these studies, as well as results from 4 Phase II clinical studies, and other safety studies, comprised the NDA package.

The most common adverse reactions with meloxicam injection were reported in ≥2% of patients treated, and at a greater frequency than placebo. These reactions included constipation, increased gamma-glutamyl transferase, and anemia.

REFERENCE

Baudax Bio Announces FDA Approval of ANJESO™ for the Management of Moderate to Severe Pain [news release]. Malvern, PA; February 20, 2020: Baudax Bio website. https://www.globenewswire.com/news-release/2020/02/20/1988253/0/en/Baudax-Bio-Announces-FDA-Approval-of-ANJESO-for-the-Management-of-Moderate-to-Severe-Pain.html Accessed February 21, 2020.