Psych and neu­ro R&D notch a win as BioX­cel gets FDA ap­proval for schiz­o­phre­nia, bipo­lar dis­or­der-re­lat­ed ag­i­ta­tion

While drug de­vel­op­ment for neu­ro and psy­chi­a­try are no­to­ri­ous­ly slug­gish, the fields took a step for­ward Wednes­day with the lat­est FDA ap­proval.

BioX­cel Ther­a­peu­tics, a New Haven, CT biotech, an­nounced the ap­proval ear­ly Wednes­day for its lead pro­gram dexmedeto­mi­dine, a sub­lin­gual film tak­en oral­ly. The drug, which will be known as Igal­mi, is in­di­cat­ed to treat ag­i­ta­tion as­so­ci­at­ed with schiz­o­phre­nia and bipo­lar I or II dis­or­der and is the com­pa­ny’s first drug to get past the FDA fin­ish line.

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