Drugs

FDA Rejects Axsome’s Fibromyalgia Drug Application

Axsome Therapeutics says it will conduct another clinical trial of fibromyalgia drug AXS-14 (esreboxetine) following an FDA refusal to file letter that found its NDA was not complete enough to permit a substantive review. The letter cited one of two placebo-controlled trials included in the submission because of its flexible-dose design and eight-week primary endpoint, which was considered inadequate, according to the company.

FDA’s letter did not raise any questions relating to the positive results of the studies, both of which met their primary endpoints. “To address the FDA’s feedback, Axsome will conduct an additional controlled trial, which will use a fixed-dose paradigm,” Axsome says, adding that it will also feature a 12-week evaluation period.

Esreboxetine is described by the company as a selective norepinephrine reuptake inhibitor being developed for fibromyalgia, a chronic and often debilitating disorder marked by widespread pain, fatigue, sleep disturbances, and cognitive impairment.

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