FDA to Review NDA Using Catalent Technology

The U.S. Food and Drug Administration (FDA) accepted for review OPKO Health’s new drug application (NDA) for a treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s OptiShell softgel technology as its delivery platform.

OPKO Health’s product, calcifediol modified-release capsules with the proposed trade name Rayaldee, has been developed for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 CKD and vitamin D insufficiency.

Catalent’s OptiShell platform allows for high-temperature encapsulation of semi-solid fill material within a non-gelatin, plant-based shell and was selected as the delivery method for Rayaldee, which will be manufactured at Catalent’s North American softgel center in St. Petersburg, FL.

OptiShell capsules utilize a patented shell derived from plant polysaccharides that are ideally suited for the encapsulation of higher melting-point fill formulations, like Rayaldee. As a result, soft capsules containing semi-solid matrices for modified-release of poorly soluble and/or poorly permeable drug compounds are now an option for drug developers.

“Rayaldee represents the first time that a semi-solid fill drug product has been delivered in a softgel,” said Aris Gennadios, president, softgel technologies, Catalent. “We have worked closely on the development of Rayaldee with OPKO to bring this important new therapy to market in the most effective manner, in the shortest possible timeframe.”