Vivera Pharmaceuticals has signed an agreement with Parexel. Under the agreement, Parexel’s dedicated Biotech division, which is dedicated to support emerging biotech companies in reaching their drug development and commercialization goals, will conduct a Phase I study to evaluate the bioavailability of TABMELT technology and provide regulatory support for Vivera’s IND process with the U.S. FDA.
TABMELT is a sublingual drug delivery system featuring a unique solution where a patient can effectively dose medications simply by dissolving a tablet under the tongue. With sublingual delivery, medication bypasses the entire gastrointestinal tract, including the liver, and is delivered right to the bloodstream – often meaning the drug delivery is faster and requires a less-active dose. Parexel Biotech will conduct a clinical study on bioavailability, which is the fraction of an administered dose of unchanged drug that reaches the systemic circulation.