Drugs

FDA Advisors Nix IV Tramadol

Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-8 on 2/15 that Avenue Therapeutics did not submit adequate information to support its position that the benefits of IV tramadol outweighed its risks in managing acute pain severe enough to require an opioid in an inpatient setting. FDA had rejected Avenue NDAs for IV tramadol in 2020 and 2021 due to safety concerns.

MedPageToday reports that after the 2021 rejection, Avenue submitted a formal dispute resolution request and FDA asked for additional input from an outside panel before making a decision, leading to the joint advisory committee meeting.

The report quotes CDER Office of New Drugs medical officer Lisa Wiltrout as telling the committees that “Tramadol IV’s delayed onset of analgesia, combined with its inability to be titrated to effect, leads to a serious safety concern of additive opioid-related adverse events from use of opioids in succession, also referred to as opioid stacking.”

Advisory committee member Maryam Jowza, of the University of North Carolina at Chapel Hill, said efficacy data were demonstrated and the risk related largely to opioid stacking, which she said could be mitigated with proper use and education.

But other panelists had a different opinion. The news service quotes Stanford University School of Medicine’s Brian Bateman that “the delayed onset and the unpredictable pharmacokinetics of this drug, coupled with the inability to titrate the drug, make this quite a problematic formulation. I think we need trials to better reflect the type of setting where this drug would be administered, where opioids would be able to be used for continued pain or breakthrough pain. There’s no compelling evidence presented that there’s less abuse liability with this formulation compared to Schedule 2 opioids. We really have no data to suggest that the use of inpatient IV opioids and the differences between them could impact long-term misuse, abuse, or the development of opioid-use disorder.”

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

Read more

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