BioAlliance Pharma's Lauriad brings benefits in Ph III

27 August 2009

French drugmaker BioAlliance Pharma 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 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 (without vesicular lesion) 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, chief executive of BioAlliance Pharma.

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