Su­per­nus touts win­ning da­ta in adult AD­HD as it looks to make its case with the FDA — again — for pe­di­atric use

Less than two months af­ter be­ing re­ject­ed by the FDA for pe­di­atric pa­tients, Su­per­nus Phar­ma­ceu­ti­cals’ AD­HD pro­gram has new da­ta in an old­er pop­u­la­tion that the com­pa­ny hopes will re­verse its for­tunes. Will the agency bite?

Su­per­nus’ $SUPN SPN-812 im­proved adult pa­tients’ re­sults on an im­por­tant AD­HD symp­toms test at a sta­tis­ti­cal­ly sig­nif­i­cant rate high­er than place­bo, ac­cord­ing to topline Phase III re­sults post­ed Tues­day evening. The biotech had sought ap­proval in chil­dren ages 6 to 17, but was shot down in No­vem­ber af­ter reg­u­la­tors cit­ed con­cerns about an in-house lab used to an­a­lyze the ex­per­i­men­tal drug.

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