FDA Approves Oral Methotrexate Solution for Pediatric Leukemia

Earlier this week, the FDA approved methotrexate oral solution (Xatmep) for the treatment of pediatric patients with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis (pJIA).

Methotrexate oral solution, 2.5-mg/mL requires no preparation time, which facilitates accurate and easy dispensing at a pharmacy, according to a press release. This oral solution removes the need for needles, crushing tablets, splitting tablets, or compounding.

While the drug does require refrigeration, it can be stored for up to 60 days.

The FDA approved the use of the oral solution in children with pJIA who have not responded to or are intolerant to a first-line therapy, including non-steroidal anti-inflammatory agents. The drug is also indicated among patients with acute lymphoblastic leukemia as part of a chemotherapy maintenance regimen, according to the release.

Currently, there are no FDA-approved, ready-to-use oral methotrexate solutions indicated to treat pediatric patients who may have difficulty swallowing tablets or those with a fear of needles, according to the release. The new approval provides a resolution to the clinically unmet needs of these patients.

Additionally, the new formulation may also benefit pharmacists who no longer have to undergo the arduous process involved with crushing pills or compounding tablets into an oral solution.

Methotrexate is a folate analog metabolic inhibitor that has been used since the 1950s as an anti-cancer drug. Today, it is still used to treat cancer, as well as multiple autoimmune diseases.

“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,” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. “As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.”