Ameritox Medical Affairs VP Discusses New Method to Help Clinicians Assess Abilify Non-Adherence

March 17, 2014

Dr. Kathryn Bronstein, Vice President of Medical Affairs for Ameritox and a registered nurse, discusses the Ameritox study establishing a new testing method that can provide additional information about whether a patient is correctly taking Abilify, a powerful and widely prescribed medication used to treat serious mental illness. In the question & answer below, Dr. Bronstein talks about the impact of this new method and the study — conducted in conjunction with Georgetown, Duke and Harvard universities — for medical professionals, patients and society as a whole.

Why is this Abilify study so important?
This research is the first of its kind to develop a method to assist clinicians in assessing a patient’s non-adherence to the antipsychotic medication Abilify (aripiprazole) – the top-selling medication in the U.S. The research also allows behavioral health centers and medical professionals to make treatment recommendations based on testing with a high level of accuracy for the presence of Abilify.

Given the increases in prescriptions for atypical antipsychotic drugs, why do you think it has taken so long to develop a method for monitoring?
The development of monitoring tests takes time and technological innovation. Each antipsychotic medication is eliminated from the body in different ways, so identifying which metabolites can be found in urine is the first step in monitoring. The second step is determining the ability to test for these metabolites on a consistent basis.

Is urine monitoring more accurate than other forms of testing to ensure patients are taking prescriptions?
Urine monitoring for drugs and metabolites allows you to examine a broader window of detection. In other words, it reflects what a patient has taken in the past few days versus tests of blood or oral fluids, which indicate what the patient has taken most recently.

Has there been any reaction in the mental health and medical community from the study published in the Journal of Pharmacology & Clinical Toxicology? If so, what?
We have had clinicians reach out to learn more about OPC3373 – the aripiprazole metabolite found in urine. We expect now that we are rolling out this testing capability officially, we will see even more interest in understanding how this test works and how to use the results to improve care for patients prescribed this powerful drug.

Can you talk about how you approached this study in order to identify the proper metabolites?
When we saw the need for greater clarity in the mental health area, we sought to develop a testing process that is both quantitative and qualitative. As we started the research, we knew the expected drug and metabolite, aripiprazole and dihydroaripiprazole, often were not found in the urine of patients known to be taking the medication. However, based on documents filed with the Food and Drug Administration for the marketing approval of Abilify, we found that another metabolite of aripiprazole, OPC3373, appeared to have a higher level of urinary excretion. Testing was then developed within the laboratory and the pilot study commenced.

Why is Ameritox focused on the issue of mental illness?
Our business has long been focused on addressing the prescription medication challenges facing our country, which have been growing. Often we see increased public focus on these issues as the result of something tragic, like the recent death of Philip Seymour Hoffman from drug overdose or the mass murder at Sandy Hook Elementary School in 2012. Much like the misuse, abuse and diversion involved in prescription pain medications, there is a significant problem related to patients with mental illness not taking necessary medication. Studies show at least 50% of patients with serious mental illness go un-medicated each year. While there are numerous reasons why these patients do not take their medications, it is clear some form of regular monitoring would help behavioral health centers and medical professionals know with greater certainty whether a patient is taking their medication as prescribed and whether it’s helping them as intended.