Long-term tolerability, efficacy and acceptability of XXXX pectin nasal spray for breakthrough @entity5 .

@entity1 @entity5 @entity1286 @entity158 @entity3575
PURPOSE: Previous studies show that @entity3575 pectin nasal spray (FPNS) rapidly provides clinically meaningful @entity158 relief in the treatment of breakthrough @entity5 (BTCP). This study assessed the long-term tolerability, acceptability and consistency of effect of FPNS in @entity1 with BTCP. METHODS: @entity1 (new and rolled over from earlier controlled studies) with @entity5 experiencing one to four episodes per day of BTCP whilst taking >=  60 mg/day of @entity1286 (or equivalent) given orally for @entity5 entered an open-label 16-week safety study. Safety and tolerability were assessed by adverse events (AEs), adverse drug reactions (ADRs), withdrawal due to AEs and by nasal assessments. Acceptability assessments included ratings of overall satisfaction with each treated episode and ease of use and convenience of FPNS. Additional rescue medication and dose stability were used to evaluate the consistency of effect. RESULTS: Four hundred three @entity1 were included in the safety and intent-to-treat analysis (42,227 episodes), 356 entered the treatment phase and 110 completed 16 weeks. Overall, 24.6% of 403 @entity1 reported treatment-related treatment-emergent AEs that were generally mild/moderate and typical of opioids; 20 @entity1 discontinued treatment due to an AE (9 were ADRs). Nasal assessments revealed no clinically significant effects; 94% of FPNS-treated episodes required no additional rescue medication. More than 90% of @entity1 did not have to increase their dose during the study. @entity1 reported overall satisfaction with FPNS for 90.1% of episodes. At week 12, 96.9% of @entity1 were satisfied with the ease of use and 97.9% with the convenience of FPNS. CONCLUSIONS: FPNS was generally well tolerated and well accepted for the treatment of BTCP, and doses remained stable over the 4-month study period.
