Drugs

Amneal Plans Parkinson’s NDA for IPX-203

Amneal Pharmaceuticals says it will file an NDA for IPX-203 in mid-2022, after reporting positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated the drug in patients with Parkinson’s disease (PD) who have motor fluctuations. The trial met its primary endpoint, demonstrating superior “good on” time from baseline in hours per day at the end of the 13-week double-blind treatment period, the company says.

“Phase 3 topline results showed the study was successful in demonstrating statistically significant improvement in efficacy for IPX-203 compared to immediate-release [carbidopa-levodopa] CD/LD, even when IPX-203 was dosed on average three times per day and immediate-release CD/LD was dosed on average five times per day,” Amneal says. “The secondary endpoint for change from baseline in ‘off’ time showed IPX-203 resulted in significantly less off time compared with immediate-release CD/LD.”

IPX-203 is described by the company as a novel, oral formulation of CD/LD extended-release capsules for patients with PD who have motor fluctuations. It was developed with an innovative formulation that contains immediate-release and extended-release granules, and mucoadhesive polymers, to provide rapid absorption and maximize levodopa absorption, it says.

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