Silvergate Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved Xatmep (methotrexate) Oral Solution, a methotrexate oral solution. Xatmep is indicated for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients.
"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," Frank Segrave, President & CEO, Silvergate Pharmaceuticals said. "As a company, we continue to focus on pediatric medications that are safe, effective, and readily available."
Xatmep Oral Solution, 2.5 mg/mL, is a ready-to-use product that requires no preparation, facilitating accuracy and ease of dispensing at the pharmacy. Xatmep is manufactured under CGMPs in accordance with FDA regulations. It eliminates the need for needles, crushing or splitting tablets or for compounding tablets into a liquid formulation.
Xatmep is a folate analog metabolic inhibitor indicated for the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs) and treatment of pediatric patients with acute lymphoblastic leukemia as part of a multi-phase, combination chemotherapy maintenance regimen.