The U.S. Food and Drug Administration (FDA) has approved RediTrex, an injectable form of methotrexate, for the treatment of juvenile idiopathic arthritis (JIA), active rheumatoid arthritis, and severe psoriasis.
Methotrexate is a disease-modifying anti-rheumatic drug (DMARD) that suppresses the immune system and eases inflammation. It is one of the most frequently prescribed DMARDs, and is currently recommended as a first-line treatment for patients with JIA.
“We are delighted by the FDA approval of RediTrex for the United States,” said A.J. Kazimi, CEO and founder of Cumberland Pharmaceuticals, the company marketing RediTrex, in a press release.
“We are looking forward to bringing this important product to the patients seeking an easy-to-use methotrexate injectable,” he added.
Methotrexate is approved in the United States in oral and injectable formulations. The oral form is widely available, but the injectable formulation has increased efficacy, fewer discontinuation rates, and causes less discomfort in patients.
Yet, research has shown that JIA patients on stand-alone methotrexate often stop treatment due to lack of efficacy and to other reasons within two years, with about a third experiencing one or more adverse reactions. Most of these side effects are linked to gastrointestinal problems.
In children with JIA, use of methotrexate has been associated with nausea and vomiting. Psychological distress, such as fear and anxiety in anticipation of the next treatment, has also been described by this patient population.
According to Cumberland, RediTrex can provide greater benefits compared to the conventional methotrexate injectables currently available in the United States.
RediTrex will be available in single-dose prefilled syringes for self-administered injection under the skin (subcutaneous). It will come in eight different dosages — 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg — to be taken once per week.
The approval comes after frequent communications between Nashville-based Cumberland and the FDA. According to the company, several amendments were made to the New Drug Application of RediTrex, which was originally submitted in late 2018.
Cumberland had acquired exclusive rights to commercialize Nordic Group‘s injectable methotrexate products in the United States.