BioAlliance Announces Positive Preliminary Pivotal Phase III Results in Herpes Labialis with Acyclovir Lauriad®
News Aug 27, 2009
BioAlliance Pharma SA has announced positive preliminary results in its LIP phase III pivotal study (Lauriad® Immunocompetent Patients Study).
This multicenter randomized, double-blind, placebo controlled study compared the efficacy and safety of a single dose acyclovir Lauriad® 50mg Mucoadhesive Buccal Tablet (MBT) versus matching placebo in patients suffering from recurrent oro-facial herpes.
In the acyclovir Lauriad® patient group among the 722 patients included, the duration of episode from the first prodromal symptoms to healing was significantly decreased (p= 0.0062).
In addition, the percentage of patients with abortive lesions was increased (p=0.051) and among patients presenting primary vesicular lesions, the time to healing was reduced (p=0.058).
“These data show that acyclovir Lauriad® brings a strong clinical benefit to patients both in preventing and treating recurrent oro-facial herpes. This trial provides a good basis for a constructive dialog with the regulatory authorities. These results strongly validate the Mucoadhesive Buccal Tablet concept based on early targeted treatment”, said Dominique Costantini, President and CEO of BioAlliance Pharma.