CNS Therapeutics announced the FDA approval of Gablofen (baclofen injection) for use in the management of severe spasticity, giving healthcare providers a new, easy-to-administer and cost-effective intrathecal baclofen treatment option.  Severe spasticity is a movement disorder affecting more than 500,000 patients in the U.S. alone and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma and stroke.

Richard Penn, MD, CNS Therapeutics co-founder and chief scientific officer, implanted the industry’s first programmable intrathecal drug pump more than 25 years ago. “Until now, the evolution of intrathecal therapies has been limited to modest innovations in implantable devices,” said Penn. “With Gablofen, CNS Therapeutics is driving the industry ahead by developing new options to improve the management of debilitating neurological conditions.”

Gablofen is compatible with Medtronic‘s SynchroMed II programmable drug pumps and is offered in the same standard concentrations as Lioresal Intrathecal (baclofen injection), a drug manufactured by Novartis and marketed exclusively by Medtronic. Gablofen is easy to administer with ready-to-use vials and pre-filled syringes offering clear advantages over glass ampules including a reduction in both refill preparation time and the risk of medicine contamination.

“When we founded CNS Therapeutics, our goal was to improve on existing intrathecal therapies by addressing the concerns of patients and all caregivers involved in the treatment path,” said John Foster, CEO of CNS Therapeutics. “Gablofen marks our first FDA approval and is a significant first step in our company mission to innovate in the areas of spasticity, Parkinson’s disease and chronic, intractable pain.”

CNS Therapeutics was founded to develop and launch new intrathecal therapies and has attracted funding from Thomas, McNerney & Partners and InterWest Partners.  In addition to Gablofen, the company is also developing treatments for the management of severe pain, and is collaborating with the University of Helsinki on novel intrathecal therapies for Parkinson’s disease. This research is in part funded by a grant from the Michael J. Fox Foundation.

Date: November 23, 2010
Source: CNS Therapeutics