Breaking: FDA approves the first drug with a digital ingestion tracking system

Not many drug approvals warrant an FDA press release, but this one did and deservedly so. The US Food and Drug Administration (FDA) approved a version of the psychiatric drug Abilify (aripiprazole) equipped with the Proteus Digital Health ingestible tracking system. Abilify MyCite has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It is the first approved commercial version of a drug equipped with the Proteus Discover system, which tracks the ingestion of the pill from a sensor in the tablet activated by gastric juices to a patch worn by the patient and then to a smartphone app. The patient, caregivers, and physicians can track medication usage (timing and compliance) through the app, adjusting dosage and timing as needed.

The Proteus press release states that the rollout is gradual through select health plans and providers, targeting a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder. It is contra-indicated for pediatric patients and adults with dementia-related psychosis.

Abilify, developed by Japan’s Otsuka and originally marketed in the US with Bristol-Myers Squibb (BMS), has been generic since 2015. This Editor finds it interesting that Proteus would be combined with a now off-patent drug, creating a new one in limited release. Proteus’ original and ongoing tests were centered on combining their system with high-value (=expensive) drugs with high sensitivity as to dosage times and compliance–for instance, cardiovascular and infectious disease (hepatitis C, TB). Here we have a focus on managing serious mental illness and treatment. 

Editors (Steve and Donna) first noticed Proteus as far back as September 2009. Looking back at our early articles, Proteus has come a long way from ‘creepy’ and ‘tattletale’. With nearly half a billion dollars invested and a dozen funding rounds since 2001 (Crunchbase), approvals were long in coming–nine years from submission of patch and tablet sensor to the FDA (2008), seven years from the patch approval (2010), five years from the tablet sensor approval (2012), to release of a drug using the Proteus system. The only thing this Editor still wonders about is what happens to the sensors in the digestive tract. They contain copper, magnesium, and silicon–copper especially can be toxic. If the sensors do not dissolve completely, can this be hazardous for those with Crohn’s, colitis, or diverticulitis/diverticulosis?  Hat tip to Bertalan Meskó, MD, PhD, via Rob Dhoble, on LinkedIn.

Also, if you can stand it, a lengthy article from the New York Times with lots of back and forth about the existential threats of monitoring drugs, potential coercion (preferable to injected Abilify), how some with schizophrenia already manage, and Proteus as a ‘biomedical Big Brother’. (Some commenters appear to have the very vapors about any digital trackers, including AiCure and etectRx.)

Avatars to help schizophrenics cope with ‘the voices’

One of the most common features of schizophrenia is the inability to control the voices that tell you what to do–at minimum annoying, but sometimes urge you to harm yourself or another. Anti-psychotic drugs do not silence them in 25 percent of cases. This approach from University College London researchers puts faces to the voices–and, by letting the patient create them, gives the patient control. With a therapist, each of the 16 patients in the study created an avatar with a computer-generated face and voice ‘matching’ the ‘voice in the head’.

In up to seven 30-minute sessions, each subject interacted with their entity’s avatar, and were encouraged to oppose its threats and orders. Not only did this allow the subjects to get comfortable with the idea of standing up to the “actual” entities themselves, but because they had taken part in creating the avatars, it helped them realize that the entities actually originated within their own mind. Additionally, each subject received an MP3 recording of their sessions, which they could listen to whenever they started hearing voices again.

Almost all participants experienced a reduction in the frequency and severity of their episodes–and three of the subjects, who had been experiencing hallucinations for 16, 13 and 3.5 years, stopped hearing voices completely. The research team just received a £1.3 million (US$1.98 million) grant from the Wellcome Trust to expand the research starting in July.  Avatars help schizophrenics gain control of voices in their heads (Gizmag)