The approval came following 2 Complete Response Letters from the FDA.
The US Food and Drug Administration (FDA) has approved Recro Pharma’s intravenous (IV) meloxicam (ANJESO) for the management of moderate to severe pain nearly 1 year after issuing the company its second Complete Response Letter (CRL).
Meloxicam is a long-acting nonsteroidal anti-inflammatory drug with preferential COX-2 inhibitor that exhibits analgesic, ani-inflammatory, and antipyretic activities. The drug was designed using a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. It is now approved for the management of moderate to severe pain, and will be administered as a once-a-day bolus push.
It is the only available 24-hour, IV, COX-2 preferential, non-steroidal anti-inflammatory drug (NSAID) and offers once-daily dosing.
The FDA approval is supported by a pair of phase 3 efficacy studies and a double-blind, placebo-controlled phase 3 safety study. The NDA package included these studies and the results from another 4 phase 2 clinical trials.
The most commonly reported adverse events among treated patients included constipation, gamma-glutamyl transferase increased and anemia.
In the most recent CRL, the FDA noted delayed onset of IV meloxicam, which did not meet prescriber expectations for its category of drugs.
Recro Pharma appealed the CRL relating to the New Drug Application (NDA) for IV meloxicam in October. The appeal was granted specifically to the request that the NDA provided sufficient evidence of effectiveness and safety to support its approval. The FDA’s letter granting the appeal also stated that before the drug could be approved and legally marketed, agreed-upon labeling—prescribing information—needed to be negotiated.
The first CRL was issued to Recro Pharma in May 2018 when the FDA said the drug’s analgesic effects and selective secondary outcomes fell short of expectations.
Gerri Henwood, President and Chief Executive Officer of Baudax Bio, anticipated meloxicam will be available to the market in late April or early May of this year.
“The approval of ANJESO marks a major advancement in the treatment landscape for managing moderate to severe pain,” Henwood said in a statement. “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."