Drugs

New Tools Needed for Opioid Addiction Drugs

Officials from FDA and the National Institutes of Health say it is important to develop new tools that could lead to biomarkers to determine the efficacy of drugs to combat opioid addiction. Writing in Science Translational Medicine, the officials say that the opioid crisis and overdose epidemic gripping the U.S. “make it imperative that we develop additional treatment options for opioid-use disorders in particular and substance-use disorders generally. Achieving a more nuanced understanding of how to achieve therapeutic benefit short of periods of abstinence will facilitate the development of new treatments.”

The two agencies say they are looking to actively support and partner with the academic community, the pharmaceutical industry, and patients and their families. They note that it has been difficult to achieve FDA’s “abstinence” outcome measure for approval of new medications to treat opioid-use disorders, and developing and validating alternative meaningful outcomes could facilitate drug development.

The article notes the difficulties inherent in studying the benefits and feasibility of end points reflecting decreased use of opioids, short of any period of abstinence, for treating opioid-use disorders. To address such challenges, it says, it is important to improve the ability to measure illicit opioid use, such as by developing biomarkers of exposure that are sufficiently sensitive to measure changes in both the quantity and frequency of drug consumption.

“We are thus faced with three urgent challenges: determining how much reduction in drug use is clinically relevant, finding reliable and practical ways to measure such changes in drug use, and developing biomarkers predicting and indicative of response to new agents,” the authors say. “To meet these challenges, we need studies of how to better measure quantity and frequency of drug consumption as well as clinical or epidemiological studies to determine how much of a change in quantity or frequency of opioid consumption is associated with meaningful health and functional outcomes. This will entail research on biomarkers of drug exposure, development of better self-report measures of quantity and frequency of drug use, and studies on the relationship of changes in quantity and frequency to meaningful health outcomes.”

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