Pharmaxis and FDA Conclude SPA for Phase III Respiratory Drug
Pharmaxis and the FDA have reached an agreement on the Phase III registration trial of Bronchitol for bronchiectasis via the special protocol assessment process.
The special protocol assessment (SPA) process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug application, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.
The Phase III trial will be a randomized, placebo-controlled, double-blind investigation of Bronchitol twice daily in approximately 350 adults with bronchiectasis. Participants will be treated for 52 weeks and the primary endpoints are reduction in frequency of exacerbations and improvement in quality of life. Secondary endpoints include time to first exacerbation and duration of exacerbation. The trial includes health economic analysis and will be conducted in centers across Europe and the US.
Pharmaxis previously agreed on the trial design with the European regulatory agency (EMEA). This trial will therefore form the basis of a marketing application in both the US and Europe.
Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with cystic fibrosis, bronchiectasis and other acute and chronic pulmonary conditions.