Drugs

Durect Amending Posimir Trial After FDA Advice Letter

Durect Corp. is amending its PERSIST Phase 3 trial for Posimir, an extended-release depot utilizing the company’s SABER technology designed to continuously deliver bupivacaine, based on recommendations in an FDA advice letter. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. “This change will add to the time and cost to complete the PERSIST trial, but the company believes that a positive outcome from this trial design would result in a stronger NDA filing and potentially provide commercial advantages,” the company says. Durect notes that in cohort 2 of its BESST trial, which like PERSIST was in laparoscopic cholecystectomy patients, the control arm was also standard bupivacaine HCl and Posimir achieved a statistically significant pain reduction over 72 hours compared to the control.

PERSIST is a randomized, double-blind, parallel-group, multicenter trial designed to evaluate the safety and efficacy of Posimir for managing postoperative pain during the first three days after surgery. The primary efficacy endpoint is pain intensity on movement for 72 hours after surgery and the key secondary efficacy endpoint is the cumulative use of opioid rescue medication over 72 hours.

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