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FDA Workshop on Abuse Deterrent Opioids: Distinguishing Products in Postmarketing Surveillance to Support Category 4 Labeling

Understanding the real-world effectiveness and value of abuse-deterrent opioids depends on surveillance designed to evaluate how these formulations work in the real world, product by product, and distinguishing prescription opioids from illicitly produced street products, such as counterfeit synthetics. Drs. Sid Schnoll and Jack Henningfield both reinforced this message in a public workshop organized by... Read more »... Read More >

Opana ER: What other questions could have been asked?

PA experts observing the recent marketing withdrawal of Opana ER (oxymorphone hydrochloride) considered other data that could be examined to determine if there is something inherent to the formulation that encourages more dangerous avenues of abuse, and the impact of other external factors on real-world safety. On July 6, Endo Pharmaceuticals announced it would withdraw... Read more »... Read More >

PinneyAssociates’ Abuse Potential Assessment of Natural Supplement Kratom Finds Evidence of Public Health Benefit and Little Harm

Kratom leaf-based products, from a South East Asian tree in the coffee family, are marketed as dietary supplements and often consumed in home brewed tea-like beverages or commercial products. Several million Americans consume kratom annually to increase alertness, enhance wellbeing and occupational performance. Kratom is also used as a natural remedy for several types of... Read more »... Read More >