FDA Approves Ready-to-Use Injectable Phenylephrine HCl Formulation

Officials with the FDA have approved the first ready-to-use formulation of phenylephrine HCl (Biorphen, Eton Pharmaceuticals) for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia, according to a press release.

Previously, phenylephrine injection was only approved and available as a highly concentrated formulation, which required hospitals to manually dilute the concentrate prior to administration or purchase ready-to-use formulations from 503B compounding pharmacies.

Compounded drugs are typically associated with higher risks of medication errors because they are not required to undergo FDA premarket review, according to the release. Because the new injectable formulation does not require compounding, it reduces the risk for unsafe injection practices, medication administration errors, and sterility breaches and waste, according to Eton Pharmaceuticals.

The ready-to-use formulation can be standardized and stocked in the operating room, emergency department, and intensive care unit, as well as in crash carts throughout the hospital, according to Eton.

Additionally, the formulation’s 3-year shelf life reduces the need for hospital staff to monitor and restock as frequently as compounded phenylephrine.

“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, often have to navigate supply disruptions through these suppliers,” Heather Nixon, MD, associate professor of anesthesiology, University of Illinois at Chicago Hospital, said in a statement.

“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. This will be an important new tool for anesthesiologists, pharmacists and other hospital providers in their efforts to enhance patient safety and prevent harm,” Nixon added.

REFERENCE

Eton Pharmaceuticals Announces US FDA Approval of Biorphen (phenylephrine HCl) Injection [news release]. Eton’s website. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-biorphenr. Accessed October 22, 2019.