Acyclovir Lauriad®: US registration file submission planned end-2011
26 Aug, 2010
BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the supportive care and treatment of cancer patients, today announces that the US Food and Drug Administration (FDA) considers the positive results of the pivotal phase III study with acyclovir Lauriad® acceptable to submit a 505(b)(2) New Drug Application of the product in the United States.
Acyclovir Lauriad®, BioAlliance Pharma second product using the Lauriad® technology (Mucoadhesive Buccal Tablet), has been developed for the treatment of recurrent herpes labialis on the basis of one and only one tablet application as soon as the first signs of infection appear. As announced beginning of July, the European file submission is planned for mid-2011 based on the same clinical programme.
“This notification from the FDA confirms that acyclovir Lauriad® represents an innovation in the treatment of oro-facial herpes labialis and strengthens our position to find the adequate partner targeting dermatologists and general practitioners to successfully commercialize this opportunity”, declares Dominique Costantini, CEO of BioAlliance Pharma.