Mallinckrodt, the pharmaceuticals business of Covidien, today announced the U.S. Food and Drug Administration (FDA) approval of Gablofen ® (baclofen injection) in prefilled syringes. The Gablofen prefilled syringe was created to reduce preparation steps, helping to simplify the pump refill process for patients receiving ITB Therapy SM (Intrathecal Baclofen Therapy) to treat severe spasticity of cerebral and spinal origin.
“The launch of Gablofen prefilled syringe enhances our product portfolio and provides a known treatment in a convenient delivery technology,” said Mark Trudeau, President, Mallinckrodt. “The prefilled syringe has the opportunity to replace the traditional glass ampules and simplify the pump refill process for healthcare providers treating appropriate patients with severe spasticity.”
A Refill Convenience Kit has been re-designed to include what is needed for pump refills using Gablofen prefilled syringes. It includes snug compartments to help ensure that each component stays in place.
Gablofen was developed by CNS Therapeutics, which was recently acquired by Mallinckrodt. Gablofen prefilled syringes will be available in February 2013. Gablofen is currently available in ready-to-use vials in the following concentrations: 50 mcg/mL (screening dose), 500 mcg/mL, new 1,000 mcg/mL and 2,000 mcg/mL. Gablofen 1,000 mcg/mL, introduced in 2012, was the first new refill concentration added in 20 years.