Vivera Pharma, Parexel Ink Clinical Services Agreement

Vivera Pharmaceuticals, Inc., a pharmaceutical company focused on non-addictive pain management, has signed an agreement for clinical development services with Parexel International. Parexel's Biotech division 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.

"We are thrilled to partner with Parexel's dedicated Biotech team on this important clinical program. Parexel is a global industry leader with proven therapeutic experience in CNS applications as well as a wealth of regulatory expertise," said Dr. Jon Norman, chief scientific officer at Vivera. "Our work to advance this innovative drug delivery system could help improve the lives of many patients."

"Our due diligence to identify a Clinical Research Organization (CRO) that shares the same patient focus and values as Vivera - including quality, respect, and accountability - led us directly to Parexel," said Dr. Norman. "Parexel Biotech provides the advantages of a large CRO with the agility of a much smaller organization so partnering with them is a great fit on many levels."

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. Parexel will conduct a clinical study on bioavailability, which is the fraction of an administered dose of unchanged drug that reaches the systemic circulation.