Slide 6 – The viscosity of the solution is 2. For reference, water is 1 and milk is 3.
Slide 7 – We have an extracted Oxycodone solution of 9 to 16 mg per ml with a viscosity of 2 that can be syringed and injected. It is impossible for this to produce abuse-deterrent labeling.
Slide 8 – So how did we get here? Dr. Bob Rappaport, the now retired FDA Division Director of the Division of Anesthesia, Addiction Medicine and Pain Medicine reviewed and wrote “These features also render the product almost impossible to dissolve, syringe and inject.” Doubling down, Dr. Douglas Throckmorton, Deputy Director of the Center for Drug Evaluation Research (CDER) wrote to Dr. Janet Woodcock, Director of the Center for Drug Evaluation Research (CDER) “OCR gradually forms a viscous hydrogel (i.e. gelatinous mass) that resists passage through a needle. The in vitro testing was sufficient to demonstrate that OCR prevents Oxycodone from being drawn into a syringe to any meaningful extent.” Nothing could be further from the truth.
(It should be noted that before Dr. Rappaport retired from his prestigious position as Division Director of the Division of Anesthesia, Addiction Medicine and Pain Medicine, he had formed his own company violating FDA employee protocol. The company name was ANALGESIC CONCEPTS LLC
File Number: S530388-0
Filing State: Virginia (VA)
Filing Status: 00 Active
Filing Date: October 31, 2014
Company Age: 1 Year 7 Months
Registered Agent: Bob A. Rappaport
3219 N. Glebe Rd.
Arlington, VA 22207-0000
Principal Address: 3219 N. Glebe Rd.
Arlington, VA 22207-0000
Even though Rappaport did not file his company as an LLC until a month following his retirement from the FDA, Analgesic Concepts LLC was in existence for one year and seven months — while he was employed by the FDA, being paid by the FDA and approving dangerous opioids for the FDA.
In addition, Dr. Sharon Hertz, former Division Director of Division of Anesthesia, Addiction Medicine and Pain Medicine (replacing Rappaport) and involved with approval of opioids along with Dr. Ellen Fields, both left the FDA within the last year after a long employment record to form their own consulting company to assist companies to expedite approval of their drugs with the FDA).
Slide 9 – This process precludes reformulated OxyContin from having meaningful IV abuse-deterrent properties. Dr. Dasgupta told you there is a product-centric and people-centric part of the data. The product-centric data falls on its face and disqualifies the people-centric data.
Slide 10 – Reformulated OxyContin has no impact on intranasal abuse. Intranasal abuse of Oxycodone in any formulation is less effective, less dangerous route of abuse than oral.
Slide 11 – C-Max slide. People abuse Oxycodone to get increased blood levels. Any formulation, IR Roxicodone, oral beats nasal. You get a higher C-max and lower T-max with oral. If true, intranasal should decline and stop and oral abuse should increase. Isn’t that what happened?
Slide 12 – Oxycodone’s physiochemical properties prevent reformulated OxyContin from having meaningful intranasal abuse-deterrent properties.
Slide 13 – Epidemiological data cannot reverse the enormous increases in consumption of reformulated OxyContin.
Slide 14 – APQ for background this is the government prospectively approved volume of Oxycodone for consumption by year. The pre-reformulation volume of Oxycodone does not return for 8 years. It is not even imaginable that if OxyContin was not reformulated, we would have something worse than this. This slide is an indictment for the opioid epidemic. This is an iatrogenic epidemic sanctioned by the federal government.
Slide 15 – Reformulated OxyContin did not shift misuse, abuse and deaths to heroin. Dr. Compton published in the New England Journal of Medicine in 2016 — “Moreover, a separate study showed no significant differences between the prevalence of heroin before the introduction of the reformulation and the prevalence after the reformulated drug was available.”
Slide 16 – Reformulated OxyContin does not have, cannot have meaningful intranasal or IV abuse-deterrent properties.
Ed Thompson presented a concise and scientific rebuttal to the FDA’s unscientific approach to the fallacy in the reformulation of OxyContin. Purdue Pharma is now in bankruptcy court. Will the FDA allow the OxyContin epidemic to continue devastating lives with their eyes wide shut as Purdue Pharma reorganizes under a new name — continuing to push their blockbuster opioid, OxyContin?