Vivera Pharmaceuticals Enters Agreement Clinical Study Agreement With Parexel Biotech
Vivera Pharmaceuticals, Inc. recently announced it has signed an agreement for Clinical Development Services with Parexel International, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health, from Clinical through Commercialization. Parexel’s dedicated Biotech division will conduct a Phase 1 study to evaluate the bioavailability of TABMELT technology and provide regulatory support for Vivera’s IND process with the US 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.”
Parexel Biotech is the company’s dedicated division to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost effectively. The division builds on the company’s heritage of providing clinical, regulatory, commercial, and technology expertise with enhanced strategic consulting and asset development capabilities. Parexel has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today.
“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 in which 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. Because of this, drug delivery may be faster. And because sublingual delivery is not metabolized in the digestive system, a less-active dose may be required to produce the desired response. Parexel will conduct a clinical study on bioavailability, which is the fraction of an administered dose of unchanged drug that reaches the systemic circulation.
“This is an important milestone for Vivera. It’s the first step in a head-to-head comparison for bioavailability with our technology versus oral delivery,” said Dr. Stephen J. McColgan, Chief Medical Officer at Vivera. “We are excited to have Parexel’s team of experts working closely with us as we begin our development pathway.”
Vivera Pharmaceuticals, Inc. is an innovative, science-driven pharmaceutical company focused on opioid deterrence and cessation and non-addictive solutions for pain management. In addition to its pharmaceutical and medical device products, the company has global exclusivity to license the patented and patent-pending TABMELT sublingual drug-delivery system for the pharmaceutical use of cannabinoid compounds. Vivera Pharmaceuticals is seeking to conduct case studies and clinical trials on CBD in the TABMELT drug delivery format with the goal of gaining FDA approval for its products. The company is vertically integrated with patented technology, manufacturing capabilities and distribution for its products. For more information, visit https://viverapharmaceuticals.com.
Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do.
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