FDA Approves Ephedrine Sulfate Injection for Hypotension in Anesthesia Setting

The FDA has approved ephedrine sulfate injection (Emerphed; Nexus Pharmaceuticals, Inc.) 25 mg/5 mL and 50 mg/10 mL single-dose pre-filled syringes as a clinically important hypotension treatment for patients undergoing anesthesia. Ephedrine sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent.

The 10 mL prescription is the first ready-to-administer pre-filled syringe of this dosing size to be approved by the FDA.¹

“We are pleased to announce the addition of our latest [ephedrine sulfate injection] product to our suite of existing FDA-approved, ready-to-use ephedrine sulfate products,” said Nexus Pharmaceuticals Chief Executive Officer and President, Usman Ahmed, in a press release. “These patented products showcase Nexus’ ability to provide innovative therapies that address clinicians’ concerns about delivering efficient and safe medications. With [ephedrine sulfate injection], we look forward to transforming how patients are treated, while continuing to offer the quality they’ve come to expect.”¹

When patients are administered anesthesia during a surgical procedure, some are at risk of life-threatening hypotension that would require the immediate use of ephedrine sulfate for treatment.²

In February 2021, a team from the Medical College of Wisconsin conducted a clinical study to compare pre-diluted ephedrine sulfate injection with the commercially used concentrated ephedrine (standard does is 10 mg). They evaluated ease and possible reduction in risk of error between the ready-to-use vial and commercial product.¹

Nexus’ ephedrine sulfate injection was significantly faster to formulate, had a higher mean value of syringe accuracy, and the novel an alpha- and beta-adrenergic agonist was more accurate, performing statistically better than the concentrated ephedrine solution.²

“[Ephedrine sulfate injection] showed significantly greater compounding efficacy and ease of use compared to commercially available concentrated ephedrine in the clinical simulations,” the study authors wrote in the article.²

The authors did not observe dramatic differences in waste reduction or percent mean accuracy of syringe dosing and remaining vial volume.² In February 2021, the findings were published in a press release and the study was published in the Journal of Pharmaceutical Science and Technology by June 2021.¹

Based on the results of the study, the United States Patent and Trademark Office issued a patent for the ready-to-use injection in August 2021, 1 year after the FDA first approved it.

“In 2020, we were the first manufacturer to launch an FDA-approved ephedrine sulfate injection in a ready-to-use vial,” said Omair Ahmed, chief operating officer, in the press release. “Since that time, the market has changed and refined itself, so we are incredibly excited to introduce the next generation of ready-to-administer ephedrine sulfate products once again.”¹

References

1. Nexus Pharmaceuticals, Inc. Nexus Pharmaceuticals, Inc. Receives FDA Approval for EMERPHED® (ephedrine sulfate injection) Pre-Filled Syringe. News Release. March 1, 2023. Accessed March 2, 2023. https://www.businesswire.com/news/home/20230301005543/en
2. Sperry A, Cruikshank J, Winn A, et al. Comparison of EMERPHED® (Ephedrine Sulfate) Injection with Current Concentrated Ephedrine Products in Simulated Clinical Settings. Pharmaceutical Science and Technology. June 2021. doi: 10.11648/j.pst.20210501.14