Clients in the News – FDA Accepts Otsuka Pharmaceuticals NDA for First-Ever Digital Medication

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Otsuka Pharmaceuticals and Proteus Digital Health released a joint statement on September 10 revealing the Food and Drug Administration (FDA) accepted their new drug application (NDA) for the first sensor-embedded version of Abilify for depression.

Here’s how this hybrid drug/device product works: An ingestible sensor built into the tablet works with another sensor embedded into a wearable adhesive patch to monitor a patient’s medication-taking patterns as well as their physiological responses like rest, body angle, and activity patterns, writes MobiHealthNews.

The collected information can be viewed on a smartphone or other Bluetooth-enabled devices. Patients may give permission to have this data sent securely to physicians and/or caregivers.

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MobiHealthNews notes Abilify is prescribed to patients dealing with schizophrenia, bipolar disorder, or depression. Behavioral health conditions can affect a person’s ability to consistently take their medication so this system could give doctors early warnings, and possibly prevent the risk of a manic or schizophrenic episode.

Both companies said in their announcement the hope is that this product “can provide the patient with a treatment option to help manage symptoms while allowing the caregiver and healthcare professional to measure medication adherence and other patient metrics.”