Rx-to-OTC switches: full switch (NDA supplement), partial switch (new NDA); OTC NDA, OTC Drug Monograph, Label Comprehension Studies, Actual Use Studies

 

With our Rx-to-OTC team we have extensive experience in the area of GI therapeutics including antacids, H2 antagonists and proton pump inhibitors for daytime and nighttime heartburn, GERD and peptic/duodenal ulcers. We have designed, implemented and supervised numerous Phase III and IV clinical trials to test the efficacy and safety of these products. Additionally we have proposed and executed creative clinical trial designs for the Rx-to-OTC switch of many of these GI products.

 

Our most successful Rx-to-OTC switch activities have been in the GI area, specifically H2 antagonists, such as Zantac, Tagamet, Axid, and Pepcid; as well as Prevacid, a proton pump inhibitor.  Rx-to-OTC switch trials require subjects to be able to self-diagnose and self-treat, as well as, to identify circumstances which require physician intervention such as the development of an unexpected adverse event. Such demanding switch-specific methodology requires the development of creative and reproducible clinical trial conditions. The provocative meal scenario provides such a setting.

 

Subjects who self-diagnose heartburn are placed in a provocative meal environment and select themselves to be treated based on the recognition of appropriate symptoms. Heartburn provoking meals are utilized in numerous clinical site locations to generate data for thousands of subjects. The OTC commercial success of these products based on these results is unparalleled.

 

Our network of GI clinical sites provides a well-distributed demographic population and a trained environment for GI clinical trials. Experienced study coordinators are the key to successful implementation of study protocols and subject retention. Synergy Research has experienced personnel to execute these trials properly, and actually manage the switch development for our sponsor company.