Silvergate Pharmaceuticals, Inc., has announced that the US Food and Drug Administration (FDA) has approved Xatmep (methotrexate) oral solution, the first and only FDA-approved methotrexate oral solution, indicated for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients. Silvergate Pharmaceuticals, Inc., is headquartered in Denver, CO.

Indications: Xatmep is a folate analog metabolic inhibitor indicated for the management of pediatric patients with active 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).

Dosage/administration: Use of another formulation of methotrexate for patients requiringdosing via routes of administration other than oral is recommended. Recommended dosage for pJIA: Starting dose of 10mg/m² 1 time weekly.

Adverse reactions: Most common adverse reactions are: ulcerative stomatitis, leukopenia,nausea, abdominal distress, and elevated liver function tests. Other frequently reported adverse reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection.