FDA clears Otsuka's Abilify MyCite as first drug in US with digital ingestion tracking system

The FDA announced the approval of Otsuka Pharmaceutical's Abilify MyCite as the first drug authorised in the US with a digital ingestion tracking system. The medicine, which is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults, combines Otsuka's atypical antipsychotic Abilify (aripiprazole) with Proteus Digital Health's ingestible sensor embedded in the tablet that records that the medication was taken.

According to the FDA, the system works by sending a message from the tablet's sensor to the wearable MyCite Patch, which transmits the information to a mobile application, called MyCite APP, so that patients can track the ingestion of the medication on their smart phone. In addition, patients can also permit their caregivers and physician to access the information through a web-based portal.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," remarked Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. The agency noted that Abilify MyCite's prescribing information indicates that "the ability of the product to improve patient compliance with their treatment regimen has not been shown."

Robert McQuade, Otsuka's chief strategic officer, explained that although "we don't have any data currently to say it will improve adherence," the company will likely study that after it reaches the market. Although Abilify recently lost patent protection, McQuade said that Otsuka has exclusive rights to embed it with Proteus' sensor. "It's not intended for all patients with schizophrenia, major depressive disorder and bipolar," the executive said, adding "the physician has to be confident the patient can actually manage the system."

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In 2016, the FDA issued a complete response letter regarding the marketing application for Abilify MyCite, with the agency asking for more information, including data about the product's performance under the conditions in which it is likely to be used. The companies resubmitted the filing in May.

Commenting on the news, Otsuka president Tatsuo Higuchi said "this approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies." Higuchi noted that the "rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients." Andrew Wright, Otsuka America's vice president for digital medicine, added that Otsuka has not determined a price for Abilify MyCite.

Proteus' ingestible sensor technology was originally approved by the FDA in 2012 for use to be integrated into an inert tablet or other ingested product, such as a drug, and was later expanded to include monitoring drug adherence. The ingestible sensor received the CE mark in 2010.

Otsuka and Proteus entered into a global agreement in 2012 to develop and promote new drugs based on Otsuka's pharmaceutical products and Proteus' digital health feedback system that incorporates its sensor-based technologies.

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