Shares of Pennsylvania-based Baudax Bio are up more than 40% in premarket trading after the company announced its pain medication Anjeso was greenlit by the U.S. Food and Drug Administration.
Late Thursday, the company said the FDA approved its New Drug Application for Anjeso (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said. Baudax plans to launch the medications in the spring of this year.
Baudax Bio officially launched in November of last year as a spinout from Recro Pharma, Inc. The company launched with a pipeline that includes meloxicam and two neuromuscular blocking agents and a reversal agent for use in a surgical setting. In its pipeline, the company also has intranasal dexmedetomidine (Dex-IN), a non-opioid alpha-2 adrenergic agonist being developed for possible uses in pain or sedation.
Before Anjeso was approved, Baudax, when it was still part of Recro, had to address a Complete Response Letter the FDA issued last year. The company submitted a response package that answered concerns raised about Anjeso.
Gerri Henwood, president and chief executive officer of Baudax, said the approval is a major advancement in the “treatment landscape for managing moderate to severe pain,” particularly as the nation continues to battle the opioid crisis. With Anjeso, Henwood said Baudax is “thrilled” to provide a non-opioid therapeutic option that has the “potential to meaningfully impact the acute pain treatment paradigm.”
The active ingredient in Anjeso, meloxicam, is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. Approval of the drug was supported by data from three Phase III studies. Each of the studies tested Anjeso in patients who underwent different types of surgeries, including hip and knee replacements, as well as abdominoplasty and bunionectomy procedures. The trials showed Anjeso significantly reduced pain in these patients compared to placebo.
Trial data showed the medication is safe, with adverse reactions occurring in approximately 2% of patients. The most common reactions included constipation, an increase in the liver enzyme gamma-glutamyl transferase and anemia.
“The safety and efficacy of Anjeso have been well-established through several mid- and late-stage clinical studies,” Stewart McCallum, chief medical officer of Baudax Bio said in a statement. “Moreover, data from our Phase III 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.”
