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CEOCFO Magazine, PO Box 340
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Lynn Fosse, Senior Editor
Steve Alexander, Associate Editor
Bud Wayne, Marketing
& Production Manager
Christy Rivers -
Dr. Michael Presti
Michael Presti, MD PhD
Interview conducted by:
Lynn Fosse, Senior Editor
Published – August 23, 2021
CEOCFO: Dr. Presti, the first thing I see on the SafeRx Pharmaceuticals site is, “An answer to the American Opioid Crisis.” What is your approach?
Dr. Presti: Thank you for the question, Lynn. And let me first emphasize that the operative word in that phrase is “an” answer, because there is no such thing as “the” answer to the opioid crisis, it’s a complex problem that is going to require a multifaceted approach. The reality is that this isn’t like COVID, there is no vaccine on the way and there will never be any single “silver bullet” solution to the opioid epidemic. But SafeRx is developing a solution to a previously unaddressed dimension of this crisis responsible for nearly one-
CEOCFO: Has this been looked at before or has it been somewhat under the radar?
Dr. Presti: Well, the hazard of combining alcohol with opioids is certainly well-
And patients typically get these warnings on several different levels. It usually starts in the physician’s office when they write the prescription, but then there is generally a second level of education from the dispensing pharmacist, and then yet a third level warning right there on the label of the bottle! Stamped on a bright yellow sticker in all capital letters, “DO NOT DRINK ALCOHOL WITH THIS MEDICATION.”
So from an education and awareness standpoint, the system has several measures in place to educate and warn patients about the danger. But what the data suggest is they don’t really work; studies show that the prevalence of alcohol-
CEOCFO: Do you think that the fact that some people like alcohol and the feeling provide and also that there are so many warnings surrounding every medication you almost have to block them out to take the medication, have an effect on decisions about following the correct protocol?
Dr. Presti: That is a fantastic point! I think that we all become inured to many of these warnings, frankly because many of them are so obvious and clearly only included because some attorney on the marketing team said, “Well, we also need to say, ‘do not take Emgality® if you are allergic to Emgality.” So yes, you are absolutely right, with all the warnings we get bombarded with every day-
CEOCFO: Would you tell us about the alcohol resistant opiates you have developed?
Dr. Presti: Our Alcohol-
CEOCFO: Would there not be an effect from the alcohol?
Dr. Presti: No. What happens is that since that acetaldehyde-
CEOCFO: With the medication, if for example, someone is an alcoholic and used to drinking a lot, would they be getting the same effect as someone who rarely drinks?
Dr. Presti: The magnitude of the disulfiram-
CEOCFO: Where are you in the development process?
Dr. Presti: We have initiated our correspondence with the FDA and brought in industry consultants to help finalize our regulatory strategy. There is a pathway and a legislative policy that we intend to leverage in order to get these drugs FDA approved and on the market on a much more expedited timeline than would be typical for a new chemical entity. And there are a couple of reasons behind that. First, because all the active pharmaceutical ingredients included in these products are already individually approved by the FDA for their intended functions, by pursuing an FDA new drug application pathway called a 505(b)(2), we can pull forth those prior agency findings of safety and efficacy. This markedly narrows the scope of new studies that we need to perform to gain FDA approval for these new combination products.
The only additional human studies we will need to perform are referred to as pharmacokinetic studies. These are basically experiments to show that when our ARO combination pills are administered, the blood levels achieved for each of the pharmaceutical ingredients are equivalent over time to the blood level profiles of the reference FDA-
CEOCFO: Are you funded for your next steps at SafeRX?
Dr. Presti: Thank you for asking! As CEO, fundraising is always top-
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“The reality is that this isn’t like COVID, there is no vaccine on the way and there will never be any single “silver bullet” solution to the opioid epidemic. But SafeRx is developing a solution to a previously unaddressed dimension of this crisis responsible for nearly one-
Dr. Michael Presti