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opiA proposed opioid will stain the mouths of addicts who try to abuse it. But will — or should — the FDA OK it? An inside look.
I just came back from Washington, having sat on the FDA advisory panel to review the research on IPC Oxy, a new opioid drug application from Intellipharmaceutics.
The Chair of the panel will send a report of the questions raised and comments of the Advisory Committee to the FDA. Ultimately the decision on whether IPC Oxy should be approved will be made by the FDA and announced. The panel consisted of the combination of two advisory committees, Drugs Safety and Risk Management (DSaRM), of which I’m the Consumer Representative, and the Anesthetic and Analgesics Advisory Committee.
I cannot speak on behalf of the FDA or the panel, but I can tell you what my thoughts and opinions were after reviewing the research submitted before the meeting and having the opportunity to question the research with the sponsoring company (Intellipharmaceutics) and to participate in a discussion with the other panel members.
Adding a Visible Abuse Indicator
Intellipharmaceuticals presented IPC Oxy as an oxycodone with abuse deterrent properties. The research submitted indicated that it was about equally effective as existing Oxycontin, the brand name drug against which it was measured. And 2 of the 3 abuse deterrent properties (difficulty to crush, becoming a viscous gel when in contact with moisture) were as effective as OxyContin in most tests and more effective in becoming viscous.
However, IPC Oxy offered a 3rd abuse deterrent property — when in contact with moisture it would turn a bright blue. This is a new idea, a deterrent technique that is not on the market now. Photographs showed smears of the blue dye around the mouth (when the person chewed the crushed pill) and around the nose (when the person snorted the crushed pill).
I applaud Intellipharmaceuticals for attempting to add upon and improve abuse deterrent technology. The FDA guidance on evaluating abuse deterrent properties urges companies to develop new technologies. But Intellipharmaceuticals was requesting approval of the new drug and abuse deterrent labeling after laboratory studies. This drug and its properties had never been tested on humans.
But … What About Side Effects of this Opioid?
IPC Oxy, like all oxycodone products, would be indicated for around the clock use for long-term pain that can not be managed through other means. We were offered no studies on the human safety of this pill formulation. I had questions that were unanswered about the effect and safety of the blue dye and the more viscous gel.
The panel asked many questions of the company about the safety of the blue dye to those who use the drug properly. Does the blue dye cause stomach upset to those using it properly? How does the blue dye disperse in the body when introduced in such a concentrated form? It wouldn’t be right to put the need to stop/slow abusers before the safety of those using the pill as prescribed.
How the New Deterrent Works
The point of creating a pill that turns into a gel when in contact with water is that it makes it much more difficult to use intravenously (though not impossible). The panel asked for human studies on how this higher level of viscosity affects the non-abuser when it dissolves in the stomach and becomes a gel then. Does it cause stomach upset or nausea? Does it delay or block the medicine from stopping pain? Again, slowing abuse is important, but it should not be at the risk of harming those using the drug properly.
Turning to the question of abuse, the company could not show studies showing that the blue deterrent was effective in avoiding abuse. The company president made an emotional case that so many people who have lost their loved ones to drug abuse say, “if only I’d known.” He argued that the blue dye would ensure the abuse was visible.
But how long would it be visible? In answer to a question the company told us it would take 30 minutes of rubbing with water to remove the stain from the skin. But they had no information on using soap, makeup remover or other solvents. If it can be easily removed, what’s the point?
A colleague raised the ethical issue of shaming abusers. The blue dye was a “Scarlet Letter” stain. Abuse is a disease, and doctors are trained not to shame those with disease, but to work to heal them.
My personal conclusion was that the improvement for IV deterrence is small, the risk of adverse outcome of this opioid for both the gel properties and the dye are unknown and the efficacy over the 9 other existing oxycontin products that have abuse deterrent formulas was not shown.
I voted, along with all but one of the other panelists, to advise the FDA to not approve the drug as it was presented to us. I am looking forward to the FDA’s final determination.
