FDA Approves First Lisinopril Oral Solution

The FDA has approved Silvergate Pharmaceuticals’ Qbrelis, the first lisinopril oral solution.

The angiotensin-converting enzyme inhibitor is indicated for the treatment of hypertension for adults and children 6 years and older, reduction of signs and symptoms of systolic heart failure, and reduction of mortality in the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction.

Qbrelis enables weight-based dosing for children 6 years and older who previously relied on an adjusted adult dose. Additionally, those who have trouble swallowing lisinopril tablets may benefit from Qbrelis oral solution.

“Qbrelis provides a ready-to-use oral solution for these children with the additional assurance of an FDA-approved medication,” stated Frank Segrave, president and CEO of Silvergate Pharmaceuticals. “As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”

The drug will be available through an extensive network of pharmacies and a qualified mail-order service.

Qbrelis comes with a boxed warning concerning fetal toxicity, as it acts directly on the renin-angiotensin system, which can cause injury and death to the developing fetus.

Other adverse reactions associated with Qbrelis are headache, dizziness, and cough in those with hypertension; hypotension and chest pain in those with systolic heart failure; and hypotension and renal dysfunction in those with acute myocardial infarction.