Drugs

FDA Approves Durect Posimir for Surgical Pain

FDA has approved a Durect NDA for Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Approval was based on clinical trial data in patients undergoing arthroscopic subacromial decompression surgery with an intact rotator cuff, according to the company. The primary outcome measures were mean pain intensity and total opioid rescue analgesia administered. Posimir showed a 20%, reduction in mean pain intensity on a 0-10 point pain scale, and a 67% reduction in intravenous morphine-equivalent rescue opioid use (12 mg usage in the placebo group compared with 4 mg in the Posimir group).

Last January, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee delivered a split vote (6 to 6) on Posimir’s approval, with panel members recognizing effectiveness and safety issues in the company’s 10/2019 response to a 2014 FDA complete response letter. During the panel deliberation, some found the data too confusing to interpret, saying that it barely showed any effect over the placebo. Safety concerns, like increased surgical site bleeding and surgical site infections, were also raised by members and FDA. Some panel members who supported the drug’s approval were encouraged by its opioid-sparing properties, agreeing that reducing opioid use in the post-operative period is an important public health goal.

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