Silvergate said Xatmep is the first and only Food and Drug Administration-approved methotrexate oral solution and will be available via an extensive network of pharmacies.
Xatmep is indicated for the treatment of acute lymphoblastic leukemia and the management of polyarticular juvenile idiopathic arthritis in pediatric patients.
Silvergate noted that Xatmep Oral Solution is a ready-to-use medicine that requires no preparation, making dispensing at the pharmacy easier. The liquid formulation also is easier for young patients who have difficulty swallowing, cannot consume tablets or fear of needles/injections.
“Xatmep is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tablets or compounding into a liquid formulation,” stated Frank Segrave, president an chief executive officer of Silvergate Pharmaceuticals. “As a company, we continue to focus on pediatric medications that are safe, effective and readily available.”
Xatmep requires refrigeration but may be stored at room temperature for 60 days after dispensing to the patient, Silvergate added.