FDA Approves Biophen for Hypotension in Anesthesia Settings

October 24, 2019

New formulation improves safety for patients.

The FDA has approved Biorphen (phenylephrine HCL, Eton Pharmaceuticals) for the treatment of clinically important hypotension resulting from vasodilation in anesthesia settings. 

Biorphen is an alpha-1 adrenergic receptor agonist that can now be standardized and stocked in the operating room, emergency department, and ICU as a ready-to-use formulation. 

According to an official release from Eton Pharmaceuticals, the ability to ship a ready-to-use formulation eliminates complications that might arise from dilution (medication errors) and compounding (reduction in sterility breaches, safe injection practices, and reduction of waste). 

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“Operating rooms, emergency departments, and intensive care units are fast-paced and time-sensitive environments. Add to that the complexity of caring for patients with a wide range of critical conditions and the use of high-alert medications like phenylephrine-and you have an atmosphere primed for potential medication error,” Jared Marcucci, MD, assistant director, Community First Medical Center Department of Emergency Medicine in Chicago said in a statement. “As a practicing emergency medicine physician, the availability of an FDA-approved, ready-to-use formulation of phenylephrine is a welcome advance, providing physicians and hospital systems with an important new option that does not require compounding and can potentially help reduce the risk of medication errors and minimize harm to patients.”

“Today’s FDA approval of Biorphen addresses a critical medical need for an approved, ready-to-use standardized formulation of phenylephrine that can potentially reduce medication administration errors and improve patient safety,” said Sean Brynjelsen, chief executive officer of Eton Pharmaceuticals. "The approval of Biorphen represents an important step forward in Eton’s commitment to improving existing medicines to address unmet patient needs. We look forward to working with our manufacturing partner, Sintetica, to make Biorphen available to hospitals across the United States before the end of the year.”

Biorphen comes with warnings of potential exacerbation of angina, heart failure, or pulmonary arterial hypertension; peripheral and visceral ischemia; skin and subcutaneous necrosis; and bradycardia. 

Adverse events reported with the use of Biorphen include nausea, vomiting, and headache.