FDA Approves Abilify MyCite, a New Version of Abilify That Tracks Adherence

On Monday, the U.S. Food and Drug Administration (FDA) approved a pill its makers say will allow both patients and doctors to track whether or not it was taken. The drug tracking system is the first of its kind in the U.S.

Abilify MyCite, a pill with the ingestible sensor, is approved for the use in patients with schizophrenia, bipolar I disorder and as an add-on treatment for depression, according to the FDA. The drug itself, Abilify, manufactured by Otsuka Pharmaceuticals Co. Ltd., has been used to treat schizophrenia in the U.S. since 2002. The antipsychotic can also be used as a mood stabilizer for patients with bipolar disorder.

The sensor in the newly approved pill sends a message to a wearable patch, which then sends information to an app for the patient to view. Given permission, a patient’s doctor can also view the information.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.

Antipsychotics, like Abilify, are effective in treating 70 to 80 percent of people diagnosed with schizophrenia, according to a study published in 2015 — but only 50 percent of those within that range adhere to their medication regimen. About half of those diagnosed with bipolar disorder adhere to a long-term medication regimen, according to a study published in 2016. The rate is similar to other chronic illnesses.

DJ Jaffe, author of “Insane Consequences: How the Mental Health Industry Fails the Mentally Ill” and executive director of Mental Illness Policy Org, is a proponent of the new system for helping people remember to take their medication.

“I do see where this med could be an improvement over others because it can be monitored,” Jaffe told The Mighty. “So, if someone with schizophrenia knows they frequently forget to take their meds, they may want to elect this one, so they, or a parent or someone they trust, can be notified if they forget.”

Jaffe said he worries if it’ll cause providers to choose Abilify over other medications that may be better for a patient.

While Abilify MyCite is elective for patients and consent is needed, Rudy Caseres, a mental health advocate who is a part of The Mighty’s mental health community, said he worries about the implications of technology like this.

“I can see how Abilify MyCite would be a win for advocates of forced treatment and their misguided notion that med compliance will reduce acts of violence,” Caseres said. “However, I am a firm believer that true long-term wellness can only be achieved free of coercion and paternalism.”

According to the FDA, the tracking system has not shown whether or not it improves compliance with taking medication, and the agency warns the system shouldn’t be used to track in “real-time” because detection can be delayed.

Abilify MyCite is not approved to treat dementia-related psychosis and comes with a warning that states elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death.

Abilify MyCite will be available starting in 2018.

Thinkstock image via haryigit.