MAP PHARMA REPORTS RESULTS OF PEDIATRIC ASTHMA STUDY

Map Pharmaceuticals announced that its unit dose budesonide (UDB) drug candidate met the primary efficacy endpoints in a Phase II clinical trial. UDB is a proprietary nebulized formulation of budesonide for the treatment of pediatric asthma.

The multicenter, randomized, double-blind, placebo-controlled, U.S.-based study aimed to assess the efficacy of UDB versus placebo at two doses in patients as young as 1 year old. The highest dose evaluated in the study was equivalent to the lowest dose available of the currently marketed nebulized budesonide product.

The primary endpoints for the study were asthma control as assessed by changes in morning asthma symptom scores compared with placebo and trends in forced expiratory volume in one second. No serious adverse events were reported in the study, and UDB was well tolerated. In addition, there were no statistically significant changes in cortisol levels as compared with placebo over the duration of the study.

While not a head-to-head study, the mean nebulization time for UDB using the same nebulizer was shown to be substantially less than the published nebulization time of the currently marketed nebulizer product.

Budesonide has been used for more than 20 years with demonstrated safety and efficacy, according to the company. UDB is initially being developed as a first-line therapy for the maintenance treatment and prophylactic therapy of pediatric asthma. However, it may have applicability in other diseases such as chronic obstructive pulmonary disease, the company said.