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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 >

Medicinal Cannabis: Lessons for Scheduling and FDA’s Expectations for Respiratory Drug Delivery

Development of cannabinoid-based medicines is a rapidly growing area of interest for patients with unmet needs as well as the pharmaceutical industry. The path forward, however, is fraught with technical and regulatory issues that require a thoughtful approach early and throughout the development process. At two recent medicinal cannabinoid conferences, CannMed 2017 and the 2017... Read more »... Read More >

Drug Abuse Research and Scientific Integrity in the 21st Century

Scientific integrity: adherence to professional values and practices when conducting and applying the results of science1. Dr. Bethea (Annie) Kleykamp presented at CPDD on the subject of scientific integrity, which impacts the behavior and is the responsibility of scientist researchers, as well as journalists, healthcare providers, industry executives, legislators, regulators, and patient advocates, among others.... Read more »... Read More >