The FDA cleared Malvern, Pa.-based Baudax Bio Inc.’s injected non-opioid Anjeso (meloxicam) for the management of moderate to severe pain, alone or in combination with other analgesics that are not nonsteroidal anti-inflammatory agents (NSAIDs).

Launch of the compound – the only 24-hour intravenous (I.V.) cyclooxygenase type 2 (COX2)-preferential NSAID that offers once-daily dosing – is expected in late April or early May, said Baudax, spun out of Recro Pharma Inc. in November 2019. Shares (NASDAQ:BXRX) were trading this morning at $9.16, up $1.26, or 15%, having risen as high as $10.14.

By targeting the COX2 pathway, Anjeso reduces the biosynthesis of prostaglandin, and the approval was supported by two phase III efficacy studies testing the approach as well as one double-blind, placebo-controlled phase III safety experiment. The results from those studies, plus data from four phase II studies and other safety studies, were included in the NDA package.

Piper Sandler analyst David Amsellem likes the “sufficiently wide labeled indication for the postoperative pain management setting. We continue to believe that Anjeso will emerge as a valued addition to a treatment landscape that is very much in need of more non-opioid options,” he said in a report, adding that Anjeso sales “could easily approach those of other brand non-opioid modalities.” Included in that segment are Exparel (bupivacaine, Pacira Biosciences Inc.) and Ofirmev (acetaminophen, Mallinckrodt plc), which rack up about $470 million and $340 million per year, respectively. Amsellem reiterated his overweight rating on Baudax shares, raising the price target to $14 from $11.

The road to approval has not been smooth for meloxicam. A complete response letter (CRL) delivered to Recro in March 2019 – before Baudax was spun out – focused on the onset and duration of the drug, noting that the delayed onset fails to meet the prescriber expectations for I.V. therapies. The dispatch also cited regulatory concerns about the role of the compound as a monotherapy in acute pain, along with how it might meet patient and prescriber needs in that setting. Recro said at the time that it “strongly” disagreed with the way regulators viewed the clinical findings. And this wasn’t the first CRL. Gatekeepers said in May 2018 that “data from ad hoc analyses and selective secondary endpoints suggest that the analgesic effect does not meet the expectations of the FDA” and raised CMC-related questions aimed at “extractable and leachable data” provided in the submission, Recro said.

Things were looking up by October 2019, when the FDA granted Recro’s appeal of the CRL, saying that the move was made “specific to the request … that the NDA provides sufficient evidence of effectiveness and safety to support approval.” The agency cautioned that “before I.V. meloxicam can be approved and legally marketed, agreed-upon labeling (prescribing information) must be negotiated,” and Recro set about putting together label language that the FDA would accept.

No Comments