During the study, Sitavig was shown to deliver early, very high and prolonged concentrations of acyclovir at the replication site of the herpes virus.
Offering a simple formulation with a single application, the tablet also showed clear salivary and labial acyclovir concentrations when compared with the other antiviral drugs.
BioAlliance Pharma COO, strategy and medical affairs in charge Pierre Attali said, "This pharmacokinetic profile supported the rationale for a single administration of Sitavig to treat cold sores as soon as the first signs or symptoms occur."
The international phase III trial (LIP study) demonstrated efficacy on healing time and on pain as well as significant safety profile.
The results led to the registration of Sitavig in eight first European countries and in the US.
BioAlliance corporate business development head Aude Michel said Sitavig is the second drug of its specialty products portfolio to have obtained a market authorization in Europe and the US.
"With a market potential of hundreds of millions of dollars, we are searching a partner to commercialize Sitavig notably in the United States, which would enable to generate significant revenues to the company," Michel added.