Drugs

Adial Finishes Alcohol Abuse Drug PK Study

Adial Pharmaceuticals says it has completed with positive results its pharmacokinetic study of AD04 (ondansetron) for treating alcohol use disorder and will work with FDA on designing a Phase 3 trial. A company statement says the formulation “exhibited predictable bioavailability relative to the reference standard; near-micro doses exhibited dose proportionality in pharmacokinetic exposure; and no food effect.”

The company says AD04 (0.33 mg ondansetron taken orally twice daily) is a selective serotonin-3 receptor antagonist that acts upon the SHT3 pathway and is thought to reduce alcohol craving. It says that mode of action is distinct from, but complimentary to, the currently approved therapies for alcohol use disorder.

Prior clinical studies have indicated that patients with mutations in the SHT3 receptor may experience substantial and clinically meaningful reductions in alcohol consumption, the statement says. It says the company has already developed and successfully tested a companion diagnostic test to select patients with the specific genomic biomarker that may benefit from AD04.

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