FDA approves Xatmep, the first and only ready-to-use methotrexate oral solution.
Silvergate Pharmaceuticals, Inc., a developer of safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Xatmep (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution. Xatmep is indicated for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients.
Xatmep (methotrexate) 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. It requires refrigeration but may be stored at room temperature for 60 days after dispensing. Xatmep is available through an extensive network of pharmacies and a qualified mail-order service.
Indications
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).
- Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
Xatmep (methotrexate) Oral Solution was developed primarily, to meet the need for a ready-to-use, 2.5 mg/mL, methotrexate oral solution for the treatment of pediatric patients for the indications stated above.
Currently, there is no FDA-approved, ready-to-use oral liquid formulation of methotrexate for use by pediatric patients requiring body surface area (BSA) dosing (mg/m2) or who have difficulty swallowing or cannot consume tablets, or those with needle-phobia. Silvergate Pharmaceuticals, Inc.’s Xatmep (methotrexate) Oral Solution resolves those unmet medical needs in pediatric patients.
(Source: PR Newswire)
Filed Under: Drug Discovery
