baclofen GRS

Baclofen GRS is a once-daily, gastro-retentive system (GRS) formulation of baclofen, a skeletal muscle relaxant and antispastic agent. Baclofen acts primarily as an agonist at the gamma-aminobutyric acid type B (GABA-B) receptor in the central nervous system, reducing nerve activity in the spinal cord to decrease muscle spasticity and associated pain. The GRS formulation was developed to improve patient compliance by allowing for once-daily dosing through gastric retention technology that combines size expansion, adhesion, and flotation techniques. Baclofen GRS has been investigated for use in treating spasticity due to multiple sclerosis and other neurogenic causes. While it demonstrated efficacy on some secondary endpoints such as severity scores and reduction of spasms compared to placebo, pivotal Phase III trials did not meet their primary endpoint for loss of efficacy after discontinuation[4][5][8].