The U.S. Patent & Trademark Office (USPTO) on May 30, 2017 issued a patent on a potential breakthrough solution to the opioid epidemic. The patent is for both a drug delivery and abuse deterrence device that will be submitted to the U.S. Food & Drug Administration (FDA) for marketing clearance.
The FDA is very experienced when it comes to intelligent pill technologies, but not until the newly patented “Smart Pill Drug Delivery Device” was presented to the agency did they see a solution with potential to solve primary challenges with opioids. The FDA wants “smart pill” technology for opiates to be produced and submitted so it can be efficiently reviewed through every relevant FDA division. To that end, the FDA, in a pre-IND / pre-IDE meeting, provided Pop Test (PT) Abuse Deterrent Technologies with a roadmap of guidances to get there. www.SmartPillsSaveLives.com
The Smart Pill Drug Delivery Device prevents overdoses on prescription opioids. It also prevents the ability to counterfeit opioids. Finally, it prevents the ability to divert pills from their prescribed user to others. The “Smart Pills” communicate with each other and they “talk” to the dispensing pharmacist and sometimes to law enforcement, too. The Smart Pills know the prescribed dosage for a patient, and if exceeded, the Smart Pills warn each other to not open their capsule to release medicinal contents, and this action thereby prevents an overdose.
The Smart Pill’s also play the role of a medicinal traffic cop.
Experts say the Drug Enforcement Administration (DEA) will see this type of technology as a method to identify and confiscate illegal opioids, as they can “interrogate” the Smart Pills directly. Being able to detect diverted medication at the pill level is the key to preventing and deterring drug diversion. Interrogation of the pills directly, (e.g., using a wand, via wireless communication, or other methods), means there will be no doubt as to the content and origin of each pill.
Track-and-trace legislation known as the, “Drug Quality and Security Act”, was signed into law in 2013, but has not significantly helped stem the opioid epidemic. The Smart Pills drug delivery system, however, provides digital accountability for every pill produced – from manufacturer to shipper to pharmacy to patient. If a Smart Pill is diverted from its targeted destination, the Smart Pills self-destruct leaving the pills useless to a thief.
The Smart Pill Drug Delivery Device has attracted the interest of Google (NASDAQ: GOOGL), Facebook (NASDAQ: FB), Johnson & Johnson (NYSE: JNJ), Qualcomm (NASDAQ: QCOM), Walgreens (NASDAQ: WBA) Endo (NASDAQ: ENDP), Purdue Pharma, Glaxo Smith Kline (NYSE: GSK), Jabil (NYSE: JBL), Flextronics (NASDAQ: FLEX), Samsung (SSNLF) and others. This is potentially a key solution to solve the country’s most alarming epidemic. Companies at the forefront of technology and pharmaceuticals appreciate this technology’s ability to control the exploding market for tools to address this problem. Now that the first U.S. patent has issued, (others pending both domestic and internationally), the door is open for a collaborator to work with us to drive the program through FDA approval and then commercialization.
Neil Theise, MD, Lead Scientist for the PT companies states, “Our goal is mandatory Smart Pill delivery of every prescription opioid. This would have a major impact on the opioid epidemic. Politicians say they want to make a difference: We have the answer. Given the often stated bipartisan interests in addressing the opioid epidemic, this invention is above politics; it is purely about saving lives.”
Pop Test is looking for a meeting with President Trump’s team. With the President’s help, Smart Pills will make the difference in addressing this profound American health and addiction crisis.
About Pop Test Abuse Deterrent Technologies: The PT companies are a unique operating paradigm with a brain trust of more than 65 scientists, clinicians, physicians, lawyers, and professionals working together without salary, to make a difference in the world financed by “Impact Investors”. The PT companies created the saliva diabetes test with smart phone app and the NASH fatty liver disease saliva test. The PT companies are also developing new classes of therapeutics and are working in collaboration with the National Institute of Health, the Department of Defense and the Veterans Administration.
Lead Scientist, Dr. Neil Theise; Addiction Scientist Dr. Mark Prendergast; Drug Task Force/Pharmaceutical Diversion Expert, Commander John Burke; Head of Technology, Dr. Razvan Ene; Head of Operations, John Gregg; BD Director, Robert Van Heyningen; CEO/Inventor, Randice Altschul.