© PMBS Edwin Thompson President PMRS, Inc September 11%, 2020 9/11/2020 ——— Simply put, reformulated OxyContin does not have physicochemical properties that deter abuse Absent these properties, reformulated OxyContin is precluded from having meaningful abuse-deterrent properties. ® If you can cut it, If you have access to water, And if you have a syringe: You can IV 16mg/ml of reformulated OxyContin SSS] ©9/11/2020 @ | Division Director, CDER, Dr. Bob Rappaport “These features also render the product almost Impossible to dissolve, syringe and inject” Deputy Director, CDER, Dr. Douglas Throckmorton reporting to Dr. Woodcock "OCR gradually forms a viscous hydrogel (Le 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" @ SSS SY Reformulated OxyContin has no This process precludes impact on intranasal abuse. reformulated OxyContin from Intranasal abuse of oxycodone in having meaningful IV abuse- any formulation is a less effective deterrent properties and less dangerous route of abuse than oral @ we ——---— Oxycodone's physicochemical properties prevent reformulated — . OxyContin from having meaningful int | abuse- — deterent properties as9/11/2020 Epidemiologic data cannot reverse the enormous increases in consumption of reformulated OxyContin Reformulated OxyContin did not shift misuse, abuse, and deaths to heroin: Dr. Wilson Compton, NEJM 2016 — “Moreover, a separate study... showed no significant differences between the Prevalence of heroin use before the introduction of the reformulation and the prevalence after the reformulated drug was available.” Reformulated OxyContin does not have, and cannot have, meaningful intranasal or IV abuse-deterrent properties