Drugs

Amneal Files NDA for Parkinson’s Drug

Amneal Pharmaceuticals has submitted an NDA for IPX203, a company-described novel formulation of carbidopa/levodopa (CD/LD) extended-release capsules for treating Parkinson’s disease (PD). The submission is based on data from the pivotal Phase 3 RISE-PD clinical trial that Amneal says demonstrated more “good on” time compared to immediate-release CD/LD, “even when IPX203 was dosed on average three times per day and immediate-release CD/LD was dosed on average five times per day. The trial also showed that subjects on IPX203 demonstrated significantly less ‘off’ time compared with immediate-release CD/LD.”

“‘On’” time refers to periods when Parkinson’s symptoms are better controlled, and patients can move and function better,” Amneal says. “Extending ‘good on’ time and reducing ‘off’ time are often key goals for patients, caregivers and healthcare providers as this can provide more consistent symptom control throughout the day,” it adds.

Amneal says IPX203 contains immediate-release granules and extended-release coated beads. “The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution,” it explains. “The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the beads from disintegrating prematurely in the stomach. This formulation is distinct from Rytary (carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the FDA in 2015.”

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