The FDA today approved Abilify MyCite, the first drug in the U.S. to have an ingestible sensor embedded within the pill that can track if the medication was taken.
The drug-device combination product is indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes linked with bipolar I disorder and as an add-on treatment for depression in adults.
The “smart pill” system helps patients track the ingestion of their medication by sending a message from the pill’s sensor to a wearable patch, which then transmits the data to a mobile app. Physicians and caregivers can also see the information using a web-based portal.
The approval was granted to Otsuka Pharmaceutical (TYO:4578), but the sensor and wearable patch technology were developed by Proteus Digital Health.
In a press release, the FDA noted that Abilify MyCite’s prescribing information notes specify that the ability to boost patient compliance using this technology has not been proven and that the product should not be used to track drug ingestion in real-time.
“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Dr. Mitchell Mathis, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, said in prepared remarks. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”
In clinical trials, the most common side effects reported by patients taking Abilify were nausea, vomiting, constipation, headache, dizziness and others. Some patients also reported skin irritation at the site where the MyCite patch was placed.
Otsuka and Proteus first sought approval for the combination product in 2015, but the FDA requested further human factors investigations to evaluate use-related risks and to confirm the product’s safety and efficacy. The companies resubmitted the device’s NDA in May this year.
“This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies,” president of Otsuka, Tatsuo Higuchi, said in a press release. “We remain committed to making a difference for individual patients and their care team by helping address the challenge of objectively measuring medication ingestion. Our rollout of the Abilify MyCite system will be done in phases to obtain, and respond to, feedback from healthcare providers and their patients.”
“The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness,” Proteus president & CEO Andrew Thompson added. “Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using their smart phones, as they go about their daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with their care team about their treatment plan in a new way.”
