FDA Approves Covidien Combination Product to Treat Spasticity

The U.S. Food and Drug Administration has approved Covidien plc’s Gablofen prefilled syringes. Gablofen (a brand name of baclofen) is primarily used to treat spasticity and is in the early research stages for use for the treatment of alcoholism. The prefilled syringes reportedly were designed to cut down on preparation time and make it easier for patients on intrathecal (when a drug is introduced under the arachnoid membrane of the brain or spinal cord) Baclofen therapy. Gablofen is specifically targeted at spasticity traced to spinal and cerebral causes, and is marketed under Covidien’s pharmaceuticals brand Mallinckrodt.

“The launch of Gablofen prefilled syringe enhances our product portfolio and provides a known treatment in a convenient delivery technology,” said Mark Trudeau, president of 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.”

Prefilled syringes of Gablofen will be marketed beginning in February. The drug will be sold in vials in different concentrations.

Covidien is headquartered in Dublin, Ireland. The firm’s U.S. base is in Mansfield, Mass. The company has been quite acquisitive in the past year, scooping up several companies with the aim of diversification and development of new products and technologies. In October last year, Covidien’s pharmaceuticals business Mallinckrodt acquired CNS Therapeutics Inc., a St. Paul Minn.-based specialty pharmaceutical company, for approximately $100 million. Covidien plans to spin-off its pharmaceutical business by mid-2013 to focus on its high-margin surgical products portfolio.