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BioAlliance Announces Positive Preliminary Pivotal Phase III Results in Herpes Labialis with Acyclovir Lauriad®
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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.
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.
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