FDA pro­vides a long-de­layed OK for Kem­Pharm’s opi­oid — with strings at­tached

Twen­ty months af­ter the FDA shot down Kem­Pharm’s ap­pli­ca­tion for its pow­er­ful opi­oid Apadaz, reg­u­la­tors have come through with a long de­layed green light for the com­pa­ny to start mar­ket­ing the pain ther­a­py.

The drug is an im­me­di­ate re­lease com­bo of ben­zhy­drocodone and ac­eta­minophen, and it’s to be used for no more than 14 days at a time for acute pain that can’t be man­aged by any of the al­ter­na­tives.

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