Drugs

Adamas Pharmaceuticals Files NDA for Parkinson’s Therapy

Adamas Pharmaceuticals has submitted an NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules, indicated for treating levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. The submission is supported by efficacy and safety data from three placebo-controlled trials: EASED, EASE LID and EASE LID 3. The trials enrolled 286 patients, with 121 receiving a 340 mg dose of ADS-5102 once daily at bedtime. Two of the trials were Phase 3 studies, and they met all primary and key secondary endpoints, according to the company.

ADS-5102 is described as a chrono-synchronous amantadine therapy that is dosed once daily at bedtime to time the delivery of drug levels of amantadine to waking hours when LID episodes are most frequent and movement control is needed most. “With bedtime dosing, the amantadine plasma concentrations rise slowly during the night to avoid sleep disturbance, with peak and plateau achieved from early morning to mid-day, declining in the late afternoon and evening,” the company says. ADS-5102 is also being evaluated for treating walking impairment in multiple sclerosis patients.

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