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FDA approves CNS Therapeutics' baclofen injection drug for severe spasticity
CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.
CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.
Baclofen is compatible with Medtronic's SynchroMedII programmable drug pumps, and it is offered in the same standard concentration as Lioresal Intrathecal (Novartis).
Severe spasticity is a movement disorder affecting more than 500,000 patients in the United States and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma, and stroke.
It is the St. Paul, Minn.-based company’s first FDA approval. CNS also is developing treatments for the management of severe pain, and it is collaborating with the University of Helsinki (Finland) on novel intrathecal therapies for Parkinson’s disease. This research is partially funded by a grant from the Michael J. Fox Foundation.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
