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news.Ferring Pharma has released the results of its pivotal Phase 3 trials of Lysteda (tranexamic acid) tablets for cyclic heavy menstrual bleeding (HMB) which demonstrated that Lysteda reduced menstrual blood loss from baseline in women with cyclic HMB while maintaining safety and tolerability.
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Lysteda Phase 3 trial is a double-blind, placebo-controlled 6-month study which assessed the drug in women ages 18-49 years with HMB, defined as mean menstrual blood loss of 80ml or more per cycle, were randomised to receive Lysteda (3.9g/d) or placebo for up to 5 days per menstrual cycle through six cycles.
Women taking Lysteda also experienced improvements in limitations in social, leisure and physical activities, measured using the Menorrhagia Impact Questionnaire (MIQ), a validated patient-reported outcome instrument, to measure changes at baseline and after three treatment menstrual cycles.
Carolina Women’s Research and Wellness Center lead study investigator Andrea Lukes said that they were excited by the results of this clinical trial.
“Women receiving Lysteda met all three primary efficacy points that is a significantly greater reduction in menstrual blood loss compared with placebo, a reduction exceeding a pre-specified volume, and most importantly, a reduction considered meaningful to women,” Lukes said.
Ferring Pharma Medical Affairs vice president Edward Trott said that women in the study experienced a reduction in menstrual blood loss, as early as the first cycle of use, which was maintained throughout all treatment cycles.
“In addition to the reduction in monthly blood loss, there was an improvement in the health-related quality-of-life parameters for social, leisure and physical activities,” Trott said.