Drugs

4 New Analgesic Guidances Coming

FDA commissioner Scott Gottlieb says the agency plans to withdraw its 2014 analgesic guidance document on developing new pain drugs and replace with at least four new guidances to create a more efficient path for new product innovation. In a statement updating progress against the opioid epidemic, Gottlieb says the 2014 document typically called for a large number of studies to get a general chronic pain indication and may have been difficult to implement because it was so broad. “We’ve determined that a more focused approach would streamline drug development in specific areas,” he says.

The new guidances reportedly will recommend the study of one or two populations for innovators who wish to pursue a more limited indication for treating specific kinds of pain. Soon to be released, Gottlieb says, is a guidance to address drugs that can spare the use of opioids in treating acute pain. It will give the agency’s current thinking on how sponsors can demonstrate a clinically meaningful reduction in use of opioid pain medications when used for acute pain.

A second guidance will outline the information that FDA will ask drug makers to provide to help assess the benefits and risks when new opioid pain drugs are put into development. A third guidance will outline a path for developing extended-release local anesthetics that can serve as an alternative to the systemic use of oral opioid drugs. And a fourth planned guidance will assist sponsors with development of new non-opioid pain medications for chronic pain that can provide therapeutic alternatives to the use of opioids.

“We need to broaden our approach as this crisis continues to evolve,” Gottlieb concludes. “The epidemic is turning from one that was largely dominated by addicted formed in the medical setting, involving prescription drugs, to one that increasingly implicates the use of illicit drugs, including highly potent fentanyls.”

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