BioAlliance Pharma's Sitavig OKed by US FDA for Herpes labialis

French drugmaker BioAlliance Pharma (Euronext Paris - BIO) has received marketing authorization from the US Food and Drug Administration for Sitavig (acyclovir Lauriad) for the treatment of recurring Herpes labialis, marking the successful conclusion to the assessment procedure carried out by the American authorities.

After Loramyc (miconazole Lauriad), registered in 26 countries including the USA, where it is partnered with Vestiq (The Pharma Letter January 8), BioAlliance for the second time has successfully passed the FDA review.

Based on proprietary Lauriad technology, Sitavig - developed internally by the French firm - comes in the form of a mucoadhesive tablet which the patient places on the gum and which delivers a high concentration of acyclovir directly to the lip, the site of the cold sore infection. In a Phase III international study conducted on 775 patients, Sitavig demonstrated a high level of efficacy in terms of healing time with one single tablet containing 50mg of acyclovir and an excellent tolerance profile.