By Maimuna Maula, PharmD Candidate c/o 2026

On July 23^rd, 2025, the FDA approved VOSTALLY (ramipril) Oral Solution by Rosemont Pharmaceuticals Inc. This is an angiotensin converting enzyme (ACE) inhibitor that offers patients a once-daily dosing in an oral liquid form – a viable alternative for individuals who have difficulty swallowing pill formulations.¹

Hypertension is the leading preventable risk factor for cardiovascular disease worldwide. The prevalence has increased over the past four decades, especially in low and middle-income countries.² Almost one-half of the U.S. adult population has hypertension, with 47.7% reporting having the condition from August 2021 – August 2023 alone.³ Among these individuals, 51.2% were taking antihypertensive medication. In the general population, up to 40% of U.S. adults experience difficulties in swallowing pills.⁴ This can lead to nonadherence to their medication regimen, potentially creating significant health issues down the line. The absolute risk increase per mmHg is greater at higher blood pressures, thus even the slightest reductions of severe hypertension can be greatly beneficial.⁵

VOSTALLY is indicated for patients 55 years or older at high risk of developing a major cardiovascular event because of a coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor, such as hypertension, cholesterol issues, smoking, or microalbuminuria. This is to reduce the risk of myocardial infarctions, stroke, or death from cardiovascular causes.⁵

Ramipril’s safety has been studied in over 4,000 patients with hypertension, including 1,230 participants in U.S. controlled trials and 1,107 in international trials. Nearly 700 patients received treatment for at least one year. The overall rate of side effects was similar between ramipril and placebo groups. The most frequent reasons for stopping ramipril were cough (1.0%), dizziness (0.5%), and impotence (0.4%). In a later year-long study, cough occurred in about 12% of ramipril users, leading to treatment discontinuation in roughly 4% of cases. Among U.S. study participants, 11% were aged 65 or older, and 0.2% were 75 or older. No meaningful differences in safety or effectiveness were noted between older and younger patients, and other clinical data support similar responses across age groups. Dose adjustments are recommended for patients with reduced creatinine clearance.⁵

While VOSTALLY appears to have substantial benefits, it still holds several contraindications. It should not be used in patients with a history of angioedema or hypersensitivity to ACE inhibitors. Additionally, a full 36-hour washout period is required when transitioning to or from sacubitril/valsartan. VOSTALLY should also not be used in combination with aliskiren in diabetic patients due to the risk of severe adverse reactions. Further adverse effects include a boxed warning of fetal toxicity, hypotension, and cough as mentioned earlier.⁵

VOSTALLY is a clear, colorless, solution that contains 150 mL of ramipril 1 mg/mL. It is to be stored in a refrigerator, before opening, then at room temperature after opening, and must be used within 60 days Initial dosing for hypertension is 2.5mg to 20mg orally once daily as a single dose or equally divided doses. This is to be adjusted according to monitored blood pressure readings after 2-4 weeks of treatment. For reduction in the risk of myocardial infarctions, the dose starts as 2.5mg orally once daily per week, then increased to 5mg once daily for three weeks, and increased as tolerated to a maximum maintenance dose of 10mg orally once daily.⁵

With the FDA’s approval, VOSTALLY is expected to become a beneficial new option for managing hypertension and cardiovascular risk in older adults, especially for patient populations that have trouble swallowing pills. This simpler liquid form helps bridge gaps between medication inaccessibility and nonadherence, potentially leading to a contribution in decreasing cardiovascular disease prevalence. It is expected to be available on the market later this year in 2025.

REFERENCES

1. Bojjapally S. A sip of relief: FDA approves Liquid Ramipril (VOSTALLY) for hypertension patients with swallowing difficulties. Medtigo. August 7, 2025. Accessed August 23, 2025. https://medtigo.com/news/a-sip-of-relief-fda-approves-liquid-ramipril-vostally-for-hypertension-patients-with-swallowing-difficulties.
2. Mills KT, Stefanescu A, He J. The Global Epidemiology of Hypertension. PubMed Central. February 5, 2020. Accessed August 23, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC7998524.
3. McCloskey AP, Penson PE, Tse Y, Abdelhafiz MA, Ahmed SN, Lim EJ. Identifying and addressing pill aversion in adults without physiological‐related dysphagia: A narrative review. British Journal of Clinical Pharmacology. August 2022. Accessed August 23, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC9805106.
4. Fryar CD, Kit B, Carroll MD, Afful J. Hypertension Prevalence, Awareness, Treatment, and Control Among Adults Age 18 and Older: United States, August 2021–August 2023. Centers for Disease Control and Prevention. October 23, 2024. Accessed August 23, 2025. https://www.cdc.gov/nchs/products/databriefs/db511.htm#ref2.
5. VOSTALLY (ramipril) [package insert]. Georgia; Rosemont Pharmaceuticals Inc.; Revised 07/23/2025.

Published by Rho Chi Post