Drugs

Pacira Wants Bupivacaine/Meloxicam Studies

Pacira Pharmaceuticals is petitioning FDA not to approve any ANDA for a fixed-dose combination of bupivacaine and meloxicam unless the application “includes sufficient evidence from adequate and well-controlled studies, including those that use a factorial design, demonstrating the safety and effectiveness of the combination product. In particular, FDA should ensure that any NDA for a bupivacaine/meloxicam combination adequately addresses the significant safety concerns raised by such a combination.”

Pacira, which manufactures and distributes Exparel (bupivacaine liposome injectable suspension) to produce postsurgical local and regional anesthesia, says it is aware that Heron Therapeutics is developing a fixed-dose combination product candidate consisting of two active ingredients: bupivacaine and meloxicam for preventing post-operative pain. The petition says that based on publicly available data, it appears that Heron has conducted a Phase 3 trial comparing its combination drug only against immediate release bupivacaine and saline placebo, and not against meloxicam.

The company says it is aware of two Heron studies that may permit factorial analysis under FDA’s combination rule, but there is not enough information publicly to tell if they were conducted in a manner consistent with FDA requirements.

“Because Heron’s public statements indicate that their Phase 3 pivotal program did not include trials with a meloxicam comparator, it is unclear whether Heron has satisfied the combination rule and provided sufficient information to enable FDA to assess the safety and effectiveness of the proposed combination,” the petition says.

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