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news.BioAlliance Pharma has announced the preliminary positive results for its US pivotal Phase III clinical trial with Loramyc, mucoadhesive buccal tablets developed for the treatment of oropharyngeal candidiasis in immunocompromised population.
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Loramyc has achieved its pre-specified two co-primary endpoints both in intent to treat (ITT) and per protocol (PP) populations. The primary end point was a complete resolution of signs and symptoms (complete clinical cure). In this pivotal Phase III trial carried out according to a randomized, double-blind, double-dummy design in 577 HIV-positive patients, 290 patients received Loramyc applied once a day and 287 patients were administered clotrimazole troches five times a day, as defined during the pre-IND meeting with the FDA.
As usual in this indication, the pivotal Phase III trial was designed to demonstrate the non-inferiority versus a reference drug. All secondary endpoints were also met and the product confirmed its already established good safety profile.
This trial was conducted to support new drug application filing to market the product in the US. According to the July 2007 exclusive licensing agreement signed with Par Pharmaceutical, Strativa Pharmaceuticals, the proprietary products division of Par, will be responsible for marketing Loramyc in the US.