The Food and Drug Administration (FDA) has approved Anjeso (meloxicam injection; Baudax Bio) for the management of moderate to severe pain, alone or in combination with non-nonsteroidal anti-inflammatory drugs (NSAIDs) in adult patients.

Meloxicam is an NSAID with analgesic, anti-inflammatory, and antipyretic properties. Anjeso contains 30mg of meloxicam per mL and is administered as a once-daily intravenous bolus injection. Because of delayed onset of analgesia, Anjeso alone is not recommended for use when rapid onset of analgesia is required.

The approval was based on data from 2 double-blind, placebo-controlled phase 3 trials evaluating the treatment in patients with postoperative pain. In the first study, patients with postoperative pain who underwent bunionectomy surgery (N=201; mean overall baseline pain intensity on the Numeric Pain Rating Scale [NPRS] was 6.8) were randomized to receive Anjeso 30mg or placebo administered once daily for 2 days starting on the day after surgery. Results showed a statistically significant reduction in the primary end point of the summed pain intensity difference over the first 48 hours (SPID48) with Anjeso compared with placebo (P=.0034). Fifty percent of patients treated with Anjeso and 49% of patients treated with placebo received rescue analgesia medication (oral oxycodone 5mg) in the first 2 hours after the start of dosing.

The second study involved patients with postoperative pain who underwent elective abdominoplasty surgery (N=219; mean overall baseline pain intensity on the NPRS was 7.3). Patients were randomized to receive Anjeso 30mg or placebo administered once daily for 2 days starting on the day of surgery. Results showed that the Anjeso treatment arm demonstrated a statistically significant reduction in SPID24 (P =.0145) compared with the placebo arm. Seventy-eight percent of patients treated with Anjeso and 78% of patients treated with placebo received rescue medication in the first 3 hours after the start of dosing.

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Regarding safety, the most common adverse reactions reported were constipation, increased gamma-glutamyl transferase, and anemia. Anjeso carries a Boxed Warning related to the risk of serious cardiovascular and gastrointestinal events. In a separate phase 3 safety study (N=721), the total occurence of patients with at least 1 serious adverse event was observed to be lower in the Anjeso group compared with the placebo group (2.6% vs 5.5%, respectively). “Data from our phase 3 safety trial demonstrated that Anjeso is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers and health systems,” said Stewart McCallum, MD, Chief Medical Officer of Baudax Bio.

Anjeso is supplied in single-dose vials containing 30mg/mL per vial. The product is expected to be available in late April or early May 2020, according to the Company.

For more information visit baudaxbio.com.