UNASSIGNED: e19604 Background: Previous randomized controlled studies have demonstrated that @entity3575 pectin nasal spray (FPNS) offers @entity158 improvement within 5 minutes with high @entity1 acceptability. Given that FPNS is administered nasally, this report specifically evaluates long-term nasal tolerability. METHODS: The 16-week, open-label study consisted of both newly titrated or rolled over @entity1 with @entity158 in @entity5 (BTPc) from earlier controlled studies. Those experiencing 1-4 BTPC episodes/day while taking >= 60 mg/day oral @entity1286 (or equivalent) were included. FPNS was used to treat <= 4 BTPc episodes/day. Nasal tolerability was assessed both by the clinician (nasal obstruction, @entity32 , discharge, mucosal color) and by subjective @entity1 assessments before the study at weeks 4, 8, 12, and 16, and at the final study visit to assess the following on a 4-point scale (0=absent, 3=severe): stuffy/blocked nose, runny nose, itching/sneezing, nose crusting/dryness, burning/discomfort, @entity548 , cough, postnasal drip, sore throat, and taste disturbance. RESULTS: This analysis included 403 @entity1 . One hundred ten of those @entity1 completed the study; 94% of 42,227 FPNS-treated episodes required no additional rescue medication. After titration to an effective dose, 90% of @entity1 required no increase in FPNS dose over the study period overall. Of the newly enrolled @entity1 , 87 had confirmed @entity2023 ; 72 (83%) were successfully titrated and entered the open-label study. Overall, objective and subjective nasal assessments showed no clinically significant effects. When subjective nasal assessments were averaged across BTPc episodes for each @entity1 , all the parameters scored <= 0.2, with most symptoms rated absent to mild. Among treatment-related adverse events (TRAEs), nasal discomfort (2.2%) and @entity5254 (1.2%) were reported by >= 1% @entity1 . None of these TRAEs were considered severe. CONCLUSIONS: In a long-term, 16-week, open-label study, FPNS has been shown to provide consistent efficacy with no clinically significant nasal TRAEs. Such nasal tolerability has been confirmed through both objective and subjective assessments.

Long-term nasal tolerability of @entity3575 pectin nasal spray in XXXX in @entity5 .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammation'] @entity2023 :: ('MESH:D006255', 'Disease') :: ['allergic/seasonal rhinitis'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity5254 :: ('MESH:D002559', 'Disease') :: ['rhinorrhea'] @entity1286 :: ('MESH:D009020', 'Chemical') :: ['morphine'] @entity158 :: ('MESH:D010146', 'Disease') :: ['breakthrough pain', 'pain'] @entity3575 :: ('MESH:D005283', 'Chemical') :: ['fentanyl']
@entity158 :: (MESH:D010146,Disease) :: ['breakthrough pain']
