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CNS Gablofen gets FDA nod

CNS Therapeutics' Gablofen (baclofen injection) has received FDA approval for use in the management of severe spasticity, giving healthcare providers a new, easy-to-administer intrathecal baclofen treatment option.

CNS claims that Gablofen is compatible with Medtronic’s SynchroMedII 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.

Additionally, 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.

CNS co-founder and chief scientific officer Richard Penn said that with Gablofen, CNS Therapeutics is driving the industry ahead by developing new options to improve the management of neurological conditions.

CNS CEO John Foster said that Gablofen marks their first FDA approval and is a significant first step in their company mission to innovate in the areas of spasticity, Parkinson’s disease and chronic, intractable pain.