Drugs

Avenue’s 2nd ‘Complete Response’ on Pain NDA

FDA has issued Avenue Therapeutics a second complete response letter on its NDA for an intravenous formulation of tramadol, indicated for treating patients in acute pain who require an opioid. The letter said that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support the company’s claim that IV tramadol in combination with other analgesics is safe and effective for the intended patient population. The agency did not identify any chemistry, manufacturing and control issues, the company says.

The first complete response letter was issued 10/2020 due to safety concerns. The FDA letter told the company that while its Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the agency had determined that it could not approve the application in its present form because the drug was not safe for the intended patient population, Avenue said at the time. “Specifically, if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed,” it says. “The likely choice would be another opioid, which would result in opioid ‘stacking’ and increases the likelihood of opioid-related adverse effects.” Additionally, FDA said it will require an adequate terminal sterilization validation prior to NDA approval.

Avenue says it disagrees with FDA’s current interpretation of the data in the NDA and intends to continue to pursue regulatory approval.

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