Opioid Update: Sarasota firm working on Smart pill dispenser

A Sarasota design firm is working to curb opioid addiction -- and save lives -- with a Smart container that dispenses pills at pre-configured time intervals.

Called PILL, the product in development by ROBRADY design is packaged similar to a Z-Pak of antibiotics. “It just happens to be Smart,” explains Rob Brady, CEO and Design Director.

The design has developed over the last six years, ever since physician assistant Afton Heitzenrater observed opioid prescriptions were being filled too quickly. Her husband Jeff and Jeff’s uncle, Joseph Bujalski, were on board to help develop a solution. Bujalski came up with the idea of controlling the timing between doses, obtained the first patent, and brought the idea to ROBRADY.

During the last 18 months, ROBRADY has invested “hundreds of thousands of dollars” to develop the concept into what it is today, Brady says. It has a broader patent pending and, through consultant and team member Rob Hartwell, is reaching out to governmental leaders and potential industry partners.

With recycled parts and a projected cost of $2 per unit, the PILL is seen as a low-cost means of controlling opioid prescriptions and discouraging unauthorized use. The prescribed pills are locked into the device until pre-set times, after which the user can remove them from the foil blister pack. The dispenser and unused pills are returned to the pharmacist, keeping them out of the hands of the black market, those who would abuse them and potentially become addicted, and community water supplies. If it's been tampered with, it's noted through the Prescription Drug Monitoring Program, along with pharmacists' comments.

The white computer chip and battery that power the device can be removed, checked, scrubbed of data and re-used. Pharmacists can retrieve usage data which can help future studies about how opioids are being used.

“In talking with physicians about this idea, they really like it,” Brady says.

PILL is a smart pill dispenser designed to curb opioid abuse.Clinical trials could begin in six to nine months, but it’s uncertain when it might be commercially available to physicians and their patients. “Obviously, we wanted this thing available yesterday,” he adds. “We’re looking for a couple million more to take it across the finish line.”

Opioid addiction and overdoses have reached epidemic proportions in the United States. According to the Centers for Disease Control and Prevention, emergency department visits for suspected opioid overdoses rose 30 percent from July 2016 through September 2017, based on data from 52 jurisdictions in 45 states.

ROBRADY received positive feedback when it took a team to Washington, D.C. in April to promote PILL, and fight the epidemic claiming more than 120 lives every day. The group met with representatives of the U.S. Department of Health and Human Services, the Food and Drug Administration, the Drug Enforcement Agency and the House Judiciary Subcommittee on Crime, along with U.S. Senators Marco Rubio, R-FL, and Lamar Alexander, R-TN.

The Opioid Crisis Response Act of 2018, which has passed unanimously out of committee, calls for package design to help prevent abuse and overdose.

“We think we have a real shot of getting this to market,” Brady says. “We’re lacking a few more partners.”

While the initial user is an individual prescribed opioids for pain, Brady doesn’t discount it may potentially have other roles. “I would love to see this thing help people that are already addicted,” he says.

But the device isn’t tamper proof, just tamper evident, which means it flags problems early. “If you smash it, if you break it, if you ‘lose it,’ you don’t get more,” he says. “Our position is we’d like to find that information out in the first 15 pills -- and not with the first overdose.”

So their initial focus is on those who potentially may become addicted. "We greatly reduce the people that we’re treating [for opioid addiction and overdoses,]” he says.

Keeping focused can help them do the job right. “We know that opioids are a huge problem,” he says. “We’ve got all kinds of things to tackle.”