FDA hits Su­per­nus with dou­ble wham­my, hand­ing biotech a CRL and RTF on same day

Su­per­nus had a bad Mon­day.

Yes­ter­day, the Mary­land biotech an­nounced that two dif­fer­ent ther­a­pies had been shot back by the FDA. The agency re­ject­ed their ap­pli­ca­tion to ap­prove SPN-812, an ex­per­i­men­tal AD­HD med­ica­tion for kids and ado­les­cents. And they re­fused to even con­sid­er an ap­pli­ca­tion for SPN-830, a con­tin­u­ous treat­ment pump meant for Parkin­son’s dis­ease.

The re­jec­tion is a sig­nif­i­cant blow to Su­per­nus, which in­vest­ed in four clin­i­cal tri­als for the AD­HD med. The FDA doesn’t dis­close its rea­son­ing for re­ject­ing a drug, but the com­pa­ny said it had to do with CMC is­sues, rather than safe­ty or ef­fi­ca­cy con­cerns. An in-house lab that does an­a­lyt­ic test­ing re­cent­ly changed lo­ca­tions, they said, rais­ing ques­tions in the agency about qual­i­ty con­trol.

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