True to the words of Ralph Ellison that, “There must be possible fiction which can arrive at the truth about human condition here and now, with all the bright magic of the fairy tale,” science has midwifed a fiction theory to a reality. A story of a digital pill christened Abilify Mycite.
The Food and Drug Administration body on Monday (13/11/2017) gave a go-ahead for Otsuka Pharmaceutical Co. Ltd to release Abilify MyCite tablet to the US pharmaceutical market. The Japanese based company collaborated with Proteus Digital Health to produce the drug mainly used in the treatment of mental disorders such as Schizophrenia. Notably, Abilify Mycite is prescribed to treat manic and mixed episodes associated with bipolar I disorder plus treatment of depression in adults.
This latest development follows a New Drug Application (NDA) filed by Otsuka Pharmaceutical Co.Ltd, back in 2015 that was granted by US FDA. The move is historical as it becomes the first time that a digital pill has been accepted in the United States.
Smart Pill to Revolutionized Medical Care
According to CEO William H. Carson, Otsuka Pharmaceuticals, the use of Digital medicine could greatly enhance adherence to drug prescription especially for patients suffering from mental illnesses. These sentiments were also echoed by Andrew Thompson, CEO at Proteus Digital Health, who expressed optimism on improved healthcare with the aid of digital medicines.
Research studies indicate that the United States Federal Government spends at least $100B- $300B yearly in washed down the drain as result of patients’ failure to adhere to prescriptions. Furthermore, it’s estimated that about 50% of these patients fail to strictly take the medication due to the long duration of drug consumption which leads to disease relapse.
It’s expected that incorporation of the digital tablet in the medical field will greatly boost the monitoring of both consumption of medicine and physiologic response of the body to drugs.
The incorporation of the digital pill has received optimistic reviews by numerous medical stakeholders as is set to alleviate the situation for mental illness patients. This is the case since patients suffering from mental disorders face stigmatization by the society due to their “violent reactions” that affects treatment methods.
Modus Operandi of the Abilify Mycite
It takes two to tango. For the digital pill to be monitored, patients would be required to wear a patch and have access to an app specifically designed by Proteus. The Abilify Mycite is manufactured in a manner in which once ingested, electric signals are triggered off by the stomach acids – containing magnesium, silicon and calcium. Once this is done, the Proteus ingestible sensor embedded on the tablet then relays information to a wearable patch and finally appears on the medical app.
Bounded by patients’ confidentiality, the medical app features a block option to restrict sharing of the drug measured variables with unauthorized recipients. Schizophrenia patients are entitled to sign consent forms before using the drugs. This allows doctors and a maximum of four other people access the data – time and date when the drug was taken.
The patch beside forming a report template network, it also designed to monitor patient general metabolic response to medication. Cases in point of such indices are heart rate and body temperature.
Not so smooth ride for the digital pill
As with any other product released, the smart tablet has received criticism from some medical practitioners such Dr. Paul Appelbaum opposed to the idea. While speaking to New York Times, the Columbia University Psychiatry said that the ailment wasn’t the best to use digital pills due to the aggressive nature of patients.
Another obstacle facing the smart pill is court orders seeking to stop the enrollment of the drugs in the market. This has been occasioned by the fear of having patient’s information leaked to unwanted parties via semi-autonomous records plus pressure on the part of patients having doctors monitoring the medication.
The major limitation associated with Ability MyCite drug as cited by the manufacturer is the contraindication of the medication on Dementia Psychosis patients as well as elderly patients. Failure to observe this warning may cause the death of a patient.
All in all, the approval by FDA is set to be historic as it opens up great possibilities of having a technologically driven medication system that would aid in an objective feedback mechanism.