FDA Approves Ready-to-Use Phenylephrine Injection (Biorphen)

Megan Brooks

October 24, 2019

The US Food and Drug Administration (FDA) has approved the first ready-to-use formulation of phenylephrine HCl injection (Biorphen, Eton Pharmaceuticals) for treatment of clinically important hypotension resulting primarily from anesthesia-associated vasodilation, the company has announced.

Previously, phenylephrine injection was only available in a highly concentrated formulation requiring manual dilution before use or in ready-to-use formulations obtained from compounding pharmacies.

"Designed for patient safety, Biorphen can be administered without diluting, which reduces the risk of medication error in often stressful clinical environments. No compounding also reduces the risk of sterility breach, can assist safe injection practices, and reduces waste," the company announced in a news release.

Ready-to-use Biorphen can be standardized and stocked in the operating room, emergency department, intensive care unit, as well as on hospital crash carts. Its 3-year shelf life reduces the need for hospital staff to monitor and restock it as often as compounded phenylephrine, they add.

"As a practicing emergency medicine physician, the availability of an FDA-approved, ready-to-use formulation of phenylephrine is a welcome advance," Jared Marcucci, MD, assistant director, Community First Medical Center Department of Emergency Medicine in Chicago, Illinois, said in the Eton release.

"Providers at the bedside need reliable, easy-to-use, safe drugs that have a consistent supply. Many hospitals outsource unapproved ready-to-use phenylephrine from 503B compounders; however, [they] often have to navigate supply disruptions through these suppliers," added Heather Nixon, MD, associate professor of anesthesiology, University of Illinois at Chicago Hospital.

"The availability of Biorphen will help address many of the underlying causes for risk and error associated with compounded phenylephrine while also reducing potential for waste associated with overdrawing medications," Nixon said. "This will be an important new tool for anesthesiologists, pharmacists, and other hospital providers in their efforts to enhance patient safety and prevent patient harm."

Eton expects Biorphen to be available to hospitals across the United States before the end of the year.

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