A best-selling antipsychotic drug soon could get so smart, patients can't lie about taking it.
The company that makes Abilify, a popular medication used to treat conditions including schizophrenia, bipolar disorder and major depression, is seeking approval from the Food and Drug Administration to insert the pills with a chip alerting doctors if a patient fails to ingest it at the right times.
If approved, Abilify would become the first digital drug with an ingestible sensor, opening the door to a new world of "smart" medications that could dramatically improve medical adherence, especially for those who might have difficulty following a doctor's directives.
"I think you're starting to see these drug products used in more innovative ways," said Wanda Moebius, vice president for public affairs at the Advanced Medical Technology Association. "We're definitely — is it fair to say — on the brink of a new area."
Doctors have prescribed Abilify, one of the top-selling drugs in the U.S., for more than a decade. Now its maker, pharmaceutical giant Otsuka, is partnering with the company that makes the sensor, Proteus Digital Health. The two companies applied to the FDA last month for approval under a new "digital drug" category the agency recently created for such types of new medications.
Used on its own since 2013, the sensor when swallowed is used to record heart rate, temperature, activity and sleeping patterns by sending signals to a wireless patch attached to a person's skin.
But by combining the sensor with Abilify — and eventually other drugs, too — doctors will be able to track and measure how well patients are following their treatments. The FDA is expected to decide by April whether or not it passes muster.
Some have poked fun at drugs with sensors, suggesting they could make patients feel as though their private behaviors are uncomfortably exposed. "Nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body and feeding information to all those people watching your every move," Comedy Central's Stephen Colbert joked in 2012.
In a study published last year in the American Medical Association's journal, Harvard researchers examined evidence of how much medications dispensed through smart packaging, such as an electronic inhaler or pillbox that collects information about use, actually improves treatment adherence.
They found limited evidence that it does, but concluded that more research is needed to find out whether digital dispensers or medications can help patients with chronic conditions over the long term.
"Longer-term evidence is needed regarding use of [electronic medication packaging] in patients with chronic illness, since EMP, like some other adherence interventions, may lose its effect over time," they wrote.
But in making its case for the combination drug, Otsuka points to research showing that many patients with severe mental illness stop taking their drugs, often because they're in denial that they need medication at all. In 2005, Columbia University researchers found that 74 percent of patients discontinued their antipsychotic medications before the full 18-month period for which they were prescribed.
"Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression," said Otsuka President William Carson.
"We believe this new digital medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population," he said.
The new smart drug could be particularly useful for ensuring the mentally ill continue taking their medications, not just by just giving doctors a way to monitor their behavior, but courts as well.
All but five states have court-ordered treatment programs, where a judge can mandate that offenders with severe mental illness stick with a treatment regimen as a condition of remaining in the community.
"These individuals already have a history of problems due to their unwillingness or inability to voluntarily comply with treatment," said D.J. Jaffe, founder of Mental Illness Policy Org. "This could be an important advance for them that would help them maintain treatment compliance."
Finding ways to help the mentally ill take their medications would become even more important should several states pass pending legislation that would encourage more use of court-ordered treatment. A federal mental health bill being pioneered by Rep. Tim Murphy, R-Pa., incentivizes such treatment through block grants.
But Jaffe also thinks digital medications could help patients beyond the seriously mentally ill, simply by reminding them to take their meds.
"Forget to take your heart med? An alert tells you," Jaffe said. "The first digital med is packed with respiridol, an antipsychotic, but I imagine it could eventually be done with other meds."
"Smart" medical devices have been on the market for years, such as drug-eluting stents, which are used to slowly release drugs into a narrow or diseased artery. But a new pill that actually transmits information directly to a doctor would be a first.
"The technology is evolving in a more complex way," said Sharon Segal, the Advanced Medical Technology Association's vice president of technology. "You've got these pills you take and then they image you all the way through."