Drugs

FDA Clinical Hold on Alcobra ADHD Trial

FDA has placed a clinical hold on an Alcobra Ltd. clinical trial called MEASURE that is evaluating its investigational drug MDX (metadoxine) extended release for treating adult patients with attention deficit hyperactivity disorder. Alcobra says it has has not yet received written notice of the clinical hold from the agency, however, based on verbal communications, the hold is due to adverse neurological findings in a pre-clinical study. “The FDA notification was not based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical studies involving MDX,” it says.

In contrast to available treatments, MDX is a not a stimulant and shows no signs of abuse or addiction, Alcobra says. “It has a differentiated mechanism of action that targets neither dopamine nor norepinephrine,” the company says. “Our two Phase II placebo-controlled studies showed significant clinical improvement in clinical symptoms with high response rates and a rapid onset of action. The trials also demonstrated favorable tolerability.”

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