Silvergate announced that the Food and Drug Administration (FDA) has approved Xatmep (methotrexate) Oral Solution for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase combination chemotherapy maintenance regimen, and for the management of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have had insufficient response to, or are intolerant of, an adequate first-line therapy, including full dose non-steroidal anti-inflammatory drugs (NSAIDs).
This approval marks Xatmep as the first ready-to-use oral solution formulation of methotrexate. To date, there is no approved oral liquid formulation of methotrexate for pediatric patients who require body surface area (BSA) dosing or who have difficulty swallowing or cannot ingest tablets or those with needle-phobia.
Xatmep contains methotrexate, a folate analog metabolic inhibitor. It interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. Its mechanism in pJIA may involve affecting the immune system.
Xatmep is available as a 2.5mg/mL strength solution in 210mL bottles. It is available through a network of pharmacies and qualified mail-order service.
For more information call (855) 379-0382 or visit SilvergatePharma.com.