Aque­s­tive nabs FDA OK for oral film ver­sion of gener­ic ALS drug

The FDA has giv­en Aque­s­tive Ther­a­peu­tics the green light to mar­ket Exser­van, its oral film for­mu­la­tion of a decades-old treat­ment for amy­otroph­ic lat­er­al scle­ro­sis.

Back in 1995 rilu­zole be­came the first FDA-ap­proved ther­a­py for ALS, which re­mains in­cur­able. Its ex­act mech­a­nism of ac­tion is un­known but it’s been pro­posed that the drug blocks the re­lease of glu­ta­mate from nerve cells, there­by al­le­vi­at­ing glu­ta­mate-in­duced de­te­ri­o­ra­tion. As a re­sult, the orig­i­nal drug was shown to de­lay symp­toms and even death.

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