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Herbert Neuman, MD

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OROS hydromorphone ER

I’m dr. herbert newman vice president medical affairs and the chief medical officer for committee and pharmaceuticals at the american pain society we’ve presented data regarding the physical and pharmacokinetic properties of our product exile which is a once-daily form of hydromorphone the data reflects the physical properties that may help inform clinicians as they

Choose products for their patients who do require continuous chronic opioid therapy specifically our data reports that x algo requires a greater bite force to actually chew the product when compared to a comparator long-acting opioid as reflected in other research more than 75 percent of abusers actually use the product orally so the impact of a formulation that

Requires greater bite force may help clinicians choose products in patients where they have some concerns around abuse or misuse similarly that data also shows that when the product is milled or ground in some way it is thicker in consistency than a comparator product specifically we compared it to olive oil and the ability to draw up the product in a syringe it

Was much more difficult to draw up our milk product versus olive oil and consistency of olive oil alone is difficult and so making it more difficult or less likely for someone seeking to abuse the product to actually try to inject exact overseas to the comparator also in this data set was a review of a model of intranasal delivery system so with in vitro model and

When exposed to this delivery system x algo had a lower amount of available product than a compare molecule all of which points to the direction that people who tuned would choose to abuse products are typically looking for material that would give them an immediate impact of the drug as well as a higher concentration of the drug as a companion abstract presented

Today looking at the pharmacokinetics of exile go the demonstration was that compared to immediate release hydromorphone extended release hydromorphone once-daily gave a lower c-max or a lower maximum concentration and that maximum concentration was achieved several hours after ingestion compared to immediate release hydromorphone which has an immediate spike on

The order of 45 minutes or so after ingestion and the spike is actually a higher concentration on a milligram per milligram basis when compared to the extended release of laura’s hydromorphone we’re very pleased to present this information at a scientific assembly like this hoping that this information will help clinicians as they choose products that would be

Most appropriate for their patients let me ask a question when you talk about crushing it aside from the bite force needed it’s harder to chew this but in crushing it is there still a way for someone to crush it and then ingest it not and not not inhale it or not use it as an injectable is that still a possibility and was there any any looking at that yes there is

Data showing that if this product is chewed or crushed and ingested the pharmacokinetics is greater than when it was taken as prescribed yet still less than the dose available in a comparator long-acting opa that was subsequently chewed and crushed similarly if the product is soaked for 24 hours in water it still maintain a higher bite required to crush it that

Interior molecule okay thank you

Transcribed from video
Herbert Neuman, MD By Chris Bubeck