Xconomy: With Narrowed Focus, Elcelyx Prepares for Diabetes Drug Trial
Summary
After spinning NaZura out in late 2013, the team intended to begin online sales of Lovidia capsules in mid-2014, with retail distribution planned for this year.The other track at Elcelyx involved the development of a “delayed-release” version of metformin—intended for use by patients with type 2 diabetes who literally cannot stomach existing formulations of metformin.The 3.6 million who have impaired renal function are also subject to an FDA “contraindication” notice, which usually precludes doctors from prescribing metformin.Baron said much of the company’s talks with FDA regulators last year was focused on the type of studies and data that would be needed to ease the regulatory restriction.The problem, Baron explained, is that existing formulations of metformin dissolve in the stomach, where the drug is absorbed into the bloodstream and acts systemically.