Cumberland Pharmaceuticals has announced the launch of RediTrex, a new line of methotrexate prefilled syringes for the treatment of polyarticular juvenile idiopathic arthritis (pJIA), active rheumatoid arthritis, and severe psoriasis in the U.S.
Eligible pJIA patients must be intolerant to or show an inadequate response to first-line therapy including full-dose non-steroidal anti-inflammatory agents.
Available in eight different doses — 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg — the therapy’s starting dose in patients with pJIA is 10 mg per square meter once weekly.
RediTrex was specifically designed for ease of handling and dosing accuracy for under-the-skin, self-administration of methotrexate in these patients, who often have limited hand dexterity.
“The RediTrex product line offers patients an important new choice in convenience, safety and dosing accuracy for their methotrexate therapy,” A.J. Kazimi, Cumberland’s CEO, said in a press release.
RediTrex’s launch — nearly a year after its approval in the U.S. for these indications — will involve two phases. The product will first be available in a limited number of centers so that Cumberland can better gauge information and patient support needs. A full national launch is then expected early next year.
While stating that RediTrex will be less expensive than autoinjectors, the company has not provided details on its price.
Methotrexate, a disease-modifying anti-rheumatic drug that suppresses the immune system and eases inflammation, is currently recommended as a first-line treatment for children with JIA.
While the therapy is available in the U.S. in oral and injectable formulations, methotrexate has been shown to be more effective if injected, resulting in fewer gastrointestinal side effects and leading to lower discontinuation rates.
Still, a previous study showed that JIA patients on stand-alone methotrexate often stop treatment due to lack of efficacy or other reasons within two years, with about a third experiencing one or more side effects, most often gastrointestinal problems. Children with JIA have also reported psychological distress, such as fear and anxiety, in anticipation of the next methotrexate dose.
“Current injectable [methotrexate] options available may not optimally meet the needs of an arthritis patient,” Cumberland stated in the release. Previously available options include a separate vial and syringe for self-injection or autoinjectors (which automatically deliver a predefined dose).
Self-administration with a separate vial and syringe can be challenging for people with disease-associated limited dexterity in their hands. In turn, autoinjectors can be a better alternative, but they preclude injection control, can be painful, resemble biologics autoinjectors — potentially causing confusion in patients about both types of therapy — and are more expensive.
According to Cumberland, RediTrex has been designed to provide greater benefits than currently available injectable methotrexate delivery systems.
As a single-dose, prefilled syringe to be administered into the belly or thigh once a week, RediTrex has a number of features to help ensure accurate and safe dosing. These include an extra-thin needle that reduces injection pain and retracts automatically when the full dose is delivered, as well as a large grip and concave plunger that allows people with limited dexterity to self-inject at a controlled speed.
In addition, each dose is color-coded to reduce potential dosing errors and is presented in a way to limit possible confusion with biologic autoinjectors.
Notably, patients requiring weekly doses lower than 7.5 mg or higher than 25 mg, or in between the available RediTrex doses, should use another formulation of methotrexate.
Cumberland acquired exclusive rights in 2016 to commercialize Nordic Group‘s injectable methotrexate products in the U.S.