Drugs

Durect Files Response to Pain Drug Rejection

Durect has submitted a detailed reply to an FDA 2014 complete response letter for Posimir (bupivacaine extended-release solution), a post-operative pain relief depot product that uses the company’s Saber technology. The product is designed to be administered directly into a surgical site to deliver bupivacaine for up to three days after surgery.

Durect says it retained the advisory services of former CDER Division of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products director Lee S. Simon to evaluate the adequacy of the existing Posimir package to address issues raised in FDA’s letter. The company expects a six-month FDA review.

The resubmission includes data from two previously completed adequate and well-controlled clinical trials, conducted in patients undergoing inguinal hernia repair and subacromial decompression (shoulder) surgeries respectively, Durect says. In these, Posimir demonstrated a significant decrease in pain and opioids consumed over the 0-72 hour period following surgery as compared to placebo, it says.

Additionally, the resubmission includes data from 16 clinical trials involving over 1,400 patients, over 850 of whom received Posimir, with the remainder in control groups. Durect further says that with safety data from the PERSIST trial included, there are now sufficient data to address FDA’s issues.

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