he Food and Drug Administration has approved the first pill embedded with a sensor that can alert a patient’s physician or caregiver when it’s been ingested, the agency announced on Monday.
The Japanese drug maker Otsuka Pharmaceutical won the approval for an upgraded version of Abilify, the antipsychotic drug first approved 15 years ago to treat schizophrenia, bipolar disorder, and depression. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.
The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. When that happens, the ingestible sensor inside it sends a message to a patch worn by the patient, which then transmits the information to a mobile app that the patient can monitor. If a patient opts to allow it, the patient’s caregivers and doctor can access the data online, too.
The FDA’s decision Monday comes a year and a half after the agency rejected the product. At the time, the agency said it needed more information about how the product is used and how human error could create risks.
Monday’s hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. The company is expected to price the new product at a markup above the original Abilify. The company is finalizing that price and expects to announce it next year, closer to the product launch, according to company spokeswoman Kimberly Whitefield.
Forgetfulness and cloudy thinking can be symptoms of the mental health conditions that Abilify is approved to treat, and patients with mental illness are known to struggle to take medication consistently. But the new product will also be labeled with a caveat: There’s no evidence that the technology can help patients take their medication as prescribed.
The landmark approval is the latest in an expansive rethinking of what constitutes a treatment. In September, the FDA approved the first mobile app to treat certain substance use disorders, developed by the Boston company Pear Therapeutics.