Breakthrough positive phase III results with acyclovir Lauriad: Primary and secondary endpoints met

11-Dec-2009 - France

BioAlliance Pharma SA announced final positive results of its pivotal phase III clinical study in immunocompetent patients with recurrent herpes labialis (LIP Study) treated with acyclovir Lauriad®. Primary and secondary endpoints have been met with marked efficacy and good tolerance.

This international multicenter randomized, double-blind, placebo-controlled study compared the efficacy and safety of a single dose of acyclovir Lauriad® 50mg Mucoadhesive Buccal Tablet (MBT) versus matching placebo in 1727 randomized and 775 treated patients suffering from recurrent herpes labialis.

A single dose of acyclovir Lauriad® 50mg MBT significantly reduced the time to healing of primary vesicular lesion (p=0.043, primary endpoint). Secondary clinical endpoints showed the duration of episode from the first prodromal symptoms to healing to be significantly decreased (p=0.0062), the percentage of patients with abortive episode (episode not progressing to vesicular lesion) to be increased (p=0.045) and the duration of abortive episode to be reduced (p=0.042).

Among patients who accepted to be followed for 9 months after this single administration of treatment, the time to recurrence to the next herpes episode was markedly delayed after the application of acyclovir Lauriad® 50mg MBT (37 days delay versus placebo, p=0.054).

Finally, acyclovir Lauriad® 50mg MBT was extremely well tolerated with very minor side effects, comparable to those observed with placebo, in particular diarrhea, headache, and local irritation were rare in contrast to systemic or topical treatments.

https://www.bionity.com/en/news/110758/breakthrough-positive-phase-iii-results-with-acyclovir-lauriad-primary-and-secondary-endpoints-met.html