FDA Approves Vostally Oral Solution, First Liquid Ramipril Formulation for Hypertension Treatment
核心洞察
The FDA approved Vostally (搜索) (ramipril) oral solution on July 23, 2025, marking the first liquid formulation of this ACE inhibitor for adults with hypertension who have difficulty swallowing tablets.
The once-daily oral liquid is indicated for treating hypertension, reducing cardiovascular risk in high-risk patients over 55, and managing post-myocardial infarction heart failure.
Rosemont Pharmaceuticals (搜索) developed this formulation to address treatment barriers for patients unable to swallow traditional solid dosage forms.
The U.S. Food and Drug Administration has approved Vostally (搜索) (ramipril) Oral Solution, the first liquid formulation of the widely-used ACE inhibitor ramipril, addressing a significant treatment gap for hypertensive patients who struggle with swallowing traditional tablets. Rosemont Pharmaceuticals (搜索) announced the July 23, 2025 approval, which offers once-daily dosing in an oral liquid form specifically designed for adults with difficulty swallowing.
Comprehensive Cardiovascular Indications
Vostally (搜索) carries multiple cardiovascular indications beyond basic hypertension management. The drug is approved for treating hypertension in adults to lower blood pressure, with the FDA noting that lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
The approval extends to high-risk cardiovascular prevention, with Vostally (搜索) indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years or older at high risk of developing a major cardiovascular event. Additionally, the drug is approved for adult patients with post-myocardial infarction heart failure to reduce the risk of cardiovascular death and hospitalization for heart failure.
Safety Profile and Contraindications
The FDA approval includes specific contraindications and safety warnings. Vostally (搜索) is contraindicated in patients with a history of angioedema or hypersensitivity to the product or any other ACE inhibitor, as well as in patients with hereditary or idiopathic angioedema.
Important drug interaction warnings include contraindication in combination with neprilysin inhibitors such as sacubitril. Healthcare providers must not administer Vostally (搜索) within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor. The drug is also contraindicated for co-administration with aliskiren in patients with diabetes.
Addressing Treatment Barriers
"We are proud to bring Vostally (搜索) to physicians to treat patients who may benefit from an ACE inhibitor but whose difficulty swallowing a tablet creates a barrier to this kind of therapy," said Jeff Bryant, President of Sabal Therapeutics (搜索), a Rosemont Company. "This oral liquid form of ramipril provides physicians with another option for treating patients."
Bryant emphasized the clinical significance of the approval, stating, "This FDA approval of Vostally (搜索) marks an important milestone in expanding treatment options for patients who have difficulty swallowing traditional tablets or capsules. We are proud to support Rosemont's commitment to delivering high-quality oral liquid medicines to the U.S. market and believe Vostally will provide a meaningful benefit to both patients and healthcare providers and payors."
Market Availability and Company Background
Vostally (搜索) will be available later this year, with full prescribing information, including boxed warning and safety profile, available at the company's website. The approval represents a significant milestone for Rosemont Pharmaceuticals (搜索), a U.K.-headquartered pharmaceutical company specialized in the development and commercialization of oral liquid medicines.
Rosemont, founded more than 50 years ago, currently sells over 130 liquid products in more than 27 markets. In July 2024, the company expanded its U.S. presence through the acquisition of Sabal Therapeutics (搜索), a U.S.-based pharmaceutical company specialized in liquid medicines, thereby strengthening their footprint in the American market.