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FDA Approves Xatmep

FDA Approves Xatmep (methotrexate) Oral Solution

Denver, April 26, 2017 — Silvergate Pharmaceuticals, Inc. leaders in the development and commercialization of innovative and 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 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.”

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. For additional information on how to obtain Xatmep, please call 1-855-379-0382.

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.

About Xatmep

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 these unmet medical needs in pediatric patients.

About Silvergate Pharmaceuticals, Inc.

Headquartered near Denver, Colorado, Silvergate Pharmaceuticals, Inc., is a privately held pharmaceutical company dedicated to leading the way in the development and commercialization of innovative pediatric medications that are safe, effective, and readily available.

Silvergate Pharmaceuticals is committed to filling the unmet needs of children, developing innovative medications that will help improve the quality of care and outcomes for pediatric patients. For more information, please visit www.silvergatepharma.com.

SOURCE Silvergate Pharmaceuticals, Inc.

Posted: April 2017

Xatmep (methotrexate) FDA Approval History

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