After receiving written guidance from the FDA in late May, says Generex, it has revised its development program for its Oral-lyn buccal insulin spray. A reorganized medical/regulatory group within the company will focus its efforts on providing information requested by the agency regarding the product’s “preclinical, clinical, toxicology, manufacturing, and regulatory and product labeling issues related to the wide variety of formulations and prior protocol changes that were made historically.” According to the company, the FDA raised no questions about the RapidMist delivery device or safety issues.
The new development plan “will focus on rapid registration in the North American major markets.” The company will conduct new studies using the final formulation, including a pharmokinetic/glucodynamic study and several small Phase 3 studies. Generex plans to meet with the FDA this year regarding the clinical plan and expects to complete the studies by the end of 2013.
The company also said that it “will seek to maximize the benefits and value of the Generex RapidMist drug delivery system for delivering new drugs, new proteins, and new enzymes for improved treatment of diabetes and other diseases.”
Read the Generex press release.
