NanoBio® Corporation today announced the initiation of two Phase 3 multicenter trials evaluating NB-001 as a topical treatment for cold sores, a step forward in their OTC licensing agreement with GlaxoSmithKline Consumer Healthcare (GSK CH).
In December 2009, GSK CH licensed exclusive rights in the United States and Canada to NB-001 for the OTC treatment of cold sores. GSK currently offers the market-leading cold sore treatment Abreva, the only OTC medicine approved by the Food & Drug Administration (FDA) to shorten cold sore healing time.
The two trials of NB-001 will be conducted in 1700 subjects at 72 clinical sites and will evaluate the effectiveness of NB-001 to reduce cold sore healing time.
"Based on the efficacy of NB-001 in Phase 2, we are very optimistic about these trials and the path to FDA approval," said Mary Flack, MD, Vice President of Clinical Research, NanoBio. "Cold sores are painful and embarrassing for the roughly 20 percent of the US population that suffer from them. The initiation of these trials marks a significant step towards the commercialization of a new treatment offering for cold sores, as well as potential other new offerings to come from our nanoemulsion-based platform technology."