FDA Rejects Otsuka, Proteus Pill With Medication Adherence Monitoring

The first U.S. regulatory test for a drug that incorporates medication adherence technology has been met with a rejection. The Food and Drug Administration issued a complete response letter to Otsuka Pharmaceutical and Proteus Digital Health for their drug/device combination of Abilify with Proteus' indigestible sensor. The Proteus technology has already been cleared in the U.S. and Europe for use in conjunction with existing medicines--not, as in this case, with it embedded in a single tablet during manufacturing.

The agency is seeking data on the performance of the product under the specific conditions in which it . . .