Filling a need for those youngsters who fear needles or find pills unmanageable, Denver-based Silvergate Pharmaceuticals Inc. recently released Xatmep, the first methotrexate oral solution to gain approval from the U.S. Food and Drug Administration.
The product — a folate analog metabolic inhibitor (a type of drug defined as a pharmacologic class by the FDA) that works by impeding cell replication — is indicated for pediatric patients with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.
For leukemia patients, the medication is meant to be taken in combination with chemotherapy, while in arthritis cases, Xatmep is recommended when other treatments have proven ineffective, whether through lack of efficacy or because of product intolerance such as NSAIDS.
"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," Silvergate President and CEO Frank Segrave, said. "As a company, we continue to focus on pediatric medications that are safe, effective and readily available."
While requiring refrigeration after 60 days of dispensing, Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, mandates no extra preparation; is easily swallowed; and requires no compounding, crushing or tablet cutting.