One year after the FDA declined to approve Proteus Digital Health and Otsuka's new sensor-embedded formulation of Otsuka's antipsychotic drug Abilify, the companies are giving it another shot, resubmitting the application with additional information. As before, the application is a New Drug Application (NDA) -- both the Proteus system itself and Abilify are already FDA cleared and approved,...
The FDA declined to approve what would have been the first mass market drug to incorporate Proteus Digital Health's ingestible sensor. The drug, a collaboration between Proteus and Otsuka Pharmaceuticals, combines the Proteus system with the antipsychotic pharmaceutical Abilify.
“While we are disappointed in the FDA’s decision not to approve this digital medicine at this time, both Otsuka and...
After years of using its digital health feedback system in clinical trials and studies, Proteus Digital Health, and partner Otsuka Pharmaceuticals, are poised to launch the first mass market drug to incorporate Proteus's ingestible sensor. The companies have submitted a sensor-embedded version of the antidepressant Abilify for FDA approval.
“Today, patients suffering from severe mental illnesses...
