Subdermal films, anti-addiction formulations and abuse-deterrent regulations are a number of ways the drug industry and regulators are looking to tackle an epidemic which has contributed to opioid-related deaths more than quadrupling in the US over the past 20 years.
But smart pills which 'talk' to each other via radio frequency signals, micro fluidics and micro-mechanical actuators, could not only provide a further option but overhaul the whole prescription opioid industry, according to its developer.
Pop Test companies – a New Jersey-based brain trust of more than 60 scientists, physicians, clinicians, lawyers and professionals working together without salary – has been awarded a patent for its drug delivery and abuse-deterrent platform and is now looking to file an application for the technology with US Food and Drug Administration (FDA).
Smart sensors
The smart pill works through an embedded microchip in the capsule which can be programmed by the drugmaker so it can only be used by the pharmacist who is then able to programme the pill for the individual patient’s needs.
The pill contains a sensor which detects other smart pills and other (opiate based) compounds already in the patient’s system, and thus will release its active ingredient at an interval or not at all if an overdose or adverse reaction is a possibility.
Usage outside this control chain impedes the release of the active ingredient. It also allows law enforcement to immediately trace-back the origin and purpose of any pill.
“The first generation of the Smart Pill drug delivery device will focus on its ability to prevent overdosing through pill to pill communication/interrogation of all Smart Pills along with the digital accountability of every pill made thus providing a complete system of track and trace,” Randi Altschul, founder of Pop Test Abuse Deterrent Technologies, told in-Pharmatechnologist.
“The second generation will focus further on the sensors to detect other drugs. The ultimate goal is that every opioid will be mandated in this drug delivery device so as to be identifiable and prevent death, theft, diversion and counterfeiting.”
FDA support
The patent, awarded by the USPTO on May 30, covers a drug delivery and abuse deterrence device and gives Pop Test a path towards FDA approval .
“The FDA expressed strong interest in our project [in a pre-IND / pre-IDE meeting] believing it could be the answer to the problem on many levels and with their guidance we believe there is a relatively simple path forward,” Altschul said.
“We are not changing the drugs we are changing the delivery system, thus the time to market is drastically reduced.”
GSK or Google?
Pop Test's business model looks to create, prove and protect its technologies then sell or license the platforms and/or companies to third parties looking to commercialise them.
“Until the patent was achieved it was difficult to move forward but now that it has we are exploring all avenues with interests from tech, pharma and data companies,” she continued.
And Altschul said taking this smart pill offering forward could be tempting for a number of companies, ranging from opioid-focused pharma firms, capsule makers to multinational tech companies looking to move into healthcare.
According to the company, GSK, Purdue Pharma, Google, Facebook, Qualcomm, Walgreens, Endo and Samsung are among interested parties.
“The technology of course would be perfect for a Purdue or Capsugel, but at the same time a Google, or Facebook who know how to manage vast amounts of data could be part of the equation too,” she said.
“The bottom line is saving lives and getting this product to market will do that. Any of the above would have the resources to do so.”