A digital drug under review by the Food and Drug Administration could offer a solution to one of the largest barriers to treating people with a serious mental illness: adherence to medication.
Japanese drugmaker Otsuka Pharmaceutical and Proteus Digital Health partnered to create the drug, which combines the antipsychotic Abilify, used to treat conditions like schizophrenia and bipolar disorder, with a digital sensor the size of a pencil tip in each pill that would allow doctors or caregivers to see whether patients are taking their medication.
“This is the wave of the future,” says Dr. E. Fuller Torrey, founder of the Treatment Advocacy Center, a mental health group. “If you have a drug with this ability then psychiatrists can put patients on it to monitor them.”
The FDA is banned by law from discussing the status of pending applications, but a review tends to take about six to 10 months. Otsuka and Proteus filed their application for the digital Abilify tablets to the FDA in early September, and according to Otsuka, a final decision should come by April of next year.
The drug device could be particularly informative in cases where a patient has been ordered to follow a treatment plan that may include medication, a practice called assisted outpatient treatment. Court-ordered treatment is controversial – some leading mental health groups have called it institutional and coercive – but others say it is vital to ensuring people get the treatment they need.
People who have a mental illness can struggle with homelessness, and often shuffle in and out of prisons and jails after confrontations with law enforcement and a lack of access to treatment. Most states allow courts to order treatment, with the exception of Connecticut, Maryland, Massachusetts, New Mexico and Tennessee, according to the Treatment Advocacy Center.
Jennifer Mathis, director of programs at the Bazelon Center for Mental Health Law, says she is concerned about the drug because of its potential for use in involuntary treatment.
“Atypical antipsychotics can have very serious side effects, and uncertain efficacy for many individuals, so we should be extremely careful about technology that could be used to promote coercive delivery of these medications,” she tells U.S. News in an email.
Otsuka and Proteus said in a press release that information about medication adherence would only be shared with others after a patient has given consent. Doctors also would be able to use the data to see how a patient is progressing and to determine whether to make any changes to the medication.
“Otsuka is committed to ensuring that the data are safe, private and secure by leveraging industry-standard security protocols to protect access to the patient’s personal health information,” Robert McQuade, executive vice president and chief strategic officer for Otsuka America Pharmaceutical, tells U.S. News in an email. “Otsuka will use appropriate technical, administrative and physical safeguards to protect personal data from loss, misuse or alteration.”
Abilify works by impacting the brain chemical dopamine to eliminate delusions and hallucinations. When taken with the digital alteration, the pills sensor would send a signal to a patch worn on the torso after it reaches the stomach. The patch then records what time the drug was taken, and also collects information about rest, body angle and activity. That information then appears on a cellphone or another Bluetooth-enabled device.
In the clinical trials for Abilify, the most commonly reported side effects were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements, anxiety, insomnia and restlessness.
The Treatment Advocacy Center estimates that about half of people with schizophrenia and 40 percent of people with bipolar disorder do not recognize that they are sick – and as a result do not see the reason to take antipsychotics.
“If you dont think youre sick, then why take any medicine? Thats one of the biggest problems were facing,” Torrey says.
In other cases, patients begin to feel better because the medication is working, so they stop taking it because they believe they are cured.
If the new drug works as intended, family members or friends responsible for that persons care could have access to their digital records. Psychiatrists could make sure their patients are doing as theyve prescribed, and those taking the medication could use their phones to remind them to do so.
This is the first time that an FDA-approved medication has been combined with a sensor and submitted for approval, but other drugs have had a similar goal of tracking adherence. Some medications, for instance, have included the vitamin riboflavin, and can be coupled with a urine test to detect whether patients are taking them.
Torrey points out that the drug could impact future medicines outside of the mental health realm, perhaps reminding older adults to take their prescriptions or ensuring that those participating in clinical trials are taking their medications as instructed, to get more accurate results. About half of patients with chronic illnesses do not take medication as prescribed.
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