Drugs

New FDA Research on Kratom Opioid Properties

New FDA research provides even stronger evidence of abusable kratom compounds’ opioid properties, according to agency commissioner Scott Gottlieb. In an online statement, Gottlieb says many questions have been raised in recent months about this botanical substance, which has been associated with 44 deaths in the U.S. so far. “Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health,” Gottlieb writes. “However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of the product and how it works in the body.”

The agency developed the Public Health Assessment via Structural Evaluation (PHASE) methodology to use 3-D computer technology to simulate how the chemical constituents of a substance are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. “In effect,” the notice says, “PHASE uses the molecular structure of a substance to predict its biological function in the body.”

FDA scientists used the model, Gottlieb says, to analyze the chemical structures of the 25 most prevalent compounds in kratom and concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives. They next analyzed the kratom compounds’ chemical structure against the software to determine its likely biologic targets. He says the model predicted that 22 of the 25 compounds in kratom bind mu-opioid receptors. “This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors,” Gottlieb concludes.

The post also covers what has been learned from reports of death associated with kratom.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome