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Designation granted by FDA for the treatment of trigeminal neuralgia.
Convergence Pharmaceuticals announced that its novel sodium channel blocker, CNV1014802 (‘802), has been granted orphan-drug designation by the US Food and Drug Administration for the treatment of trigeminal neuralgia (TN). Orphan-drug designation gives Convergence various incentives and advantages in the development of ‘802, including the potential availability of certain grants for clinical studies and assistance from the FDA with clinical protocol design. The designation also grants US market exclusivity, distinct from other types of exclusivity, for seven years if ‘802 is approved.
‘802 is a small molecule that penetrates the central nervous system and blocks Navs in a highly state-dependent fashion, while exhibiting selectivity against the 1.7 subtype. The drug is currently in a Phase II trial.
Source: Convergence Pharmaceuticals