Cat­a­lyst heads back to the FDA in search of an elu­sive OK af­ter Fir­dapse scores high in new PhI­II

About 18 months af­ter the FDA thumbed Cat­a­lyst Phar­ma­ceu­ti­cals $CPRX back to the clin­ic with a de­mand for more clin­i­cal da­ta on its lead drug Fir­dapse (am­i­fam­pri­dine phos­phate), the biotech says that the ther­a­py passed a sec­ond Phase III tri­al with fly­ing col­ors. And that suc­cess paves the way to a new drug ap­pli­ca­tion which the com­pa­ny plans to de­liv­er to the FDA in the next few months.

Re­searchers re­cruit­ed 26 pa­tients for their lat­est Phase III, which stud­ied the drug’s ef­fect on symp­toms of the ul­tra rare neu­ro­mus­cu­lar dis­ease Lam­bert-Eaton myas­thenic syn­drome. Ac­cord­ing to Coral Gables, FL-based Cat­a­lyst, Fir­dapse hit with sta­tis­ti­cal­ly sig­nif­i­cant re­sults for both co-pri­ma­ry end­points: The quan­ti­ta­tive myas­the­nia gravis score (with a p-val­ue of 0.0004) and sub­ject glob­al im­pres­sion scores (with a p-val­ue of 0.0003).

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