Pangea Pharmaceuticals has announced the launch of Sdamlo (amlodipine for oral solution) in the US.
The product is the first and only FDA-approved, patent-pending amlodipine powder formulation.
The company said Sdamlo will be available in multiple strengths, with initial availability beginning in March and additional strengths expected to launch in the coming months.
Sdamlo introduces a unique powdered oral solution for amlodipine, a key treatment for hypertension and cardiovascular disease.
This prescription-strength formulation simplifies administration and ensures precise dosing, addressing challenges faced by certain patient groups with traditional tablets and liquid forms.
The unit-dose format eliminates the need to swallow pills, making medication easier for patients and caregivers.
"Sdamlo reflects our commitment to creating better products from proven molecules and bringing them to market in a way that always puts patients first," said Tony LaViola, CEO and co-founder of Pangea Pharmaceuticals.
We are focused on identifying meaningful gaps in care and delivering solutions that improve access, simplify administration and support better outcomes.
"This launch is an important step as we continue to build a differentiated portfolio of life-enhancing products."
Sdamlo is designed for patients who struggle to swallow solid medications, including paediatric, geriatric and dysphagic populations.
It is particularly beneficial for tube-fed patients, as it eliminates the need for crushing and mixing traditional medications, reducing the risk of dosing variability and tube clogging.
The ready-to-administer liquid format ensures accurate enteral delivery, making it ideal for hospitals and long-term care facilities where efficiency and ease of administration are essential.
Differentiated formulation designed for real-world use
Pangea's new powder for oral solution formula uses a patent-pending lyophilisation process to freeze-dry the active ingredient, which the company says supports uniform distribution, enhances stability and gives reliable therapeutic performance.
It added that the product offers the following key advantages:
- easy-to-swallow format that eliminates the need for tablets and reduces aspiration risk
- precision unit-dose delivery with no measuring, shaking, or stirring required
- alcohol-free, preservative-free and sucralose-free formulation, enhancing suitability for sensitive populations
- no refrigeration required, supporting flexibility across care settings
- "no guessing" dosing, designed to ensure patients receive the exact prescribed amount every time.
Supporting clinical and operational needs
Pangea Pharmaceuticals said in its statement that Sdamlo's unit-dose format has been designed to deliver value beyond the patient experience, supporting pharmacy workflow efficiency and ensuring consistent administration.
In institutional and clinical settings, the product can help reduce preparation complexity and eliminate variability associated with alternative liquid preparation methods, offering a more streamlined and reliable option for healthcare providers.
Pangea added that Sdamlo will be commercialised in partnership with Brillian Pharma.
"We are proud to partner with Pangea Pharmaceuticals on the U.S. commercialisation of Sdamlo, a product based on Brillian's proprietary platform technology," said Dr Nolan Wang, co-founder and Chief Technology Officer of Brillian Pharma.
This collaboration reflects a shared commitment to advancing differentiated formulations of widely prescribed therapies while addressing challenges associated with traditional solid oral dosage forms.
"Sdamlo provides a more flexible option for patients who have difficulty swallowing, including pediatric and geriatric populations."
The launch marks a broader milestone for Pangea Pharmaceuticals as the company continues to build a selective, growing pipeline of products designed to improve access and enhance patient care.
The company added that it was actively evaluating additional opportunities to collaborate with partners seeking to bring differentiated products to market.
"We are building a thoughtful and intentional portfolio centred on solutions that make a meaningful difference in patients' lives," added LaViola.
Sdamlo is an early example of what this platform can deliver and we see a significant opportunity to expand our pipeline through strategic partnerships and continued growth.