Oral glucocorticosteroids have beneficial effects in nasal polyposis. Effects with nasal corticosteroids have been inconsistent. Two randomized, double-blind, parallel group, multicenter (n=354, 310), 4-month studies were conducted to compare MFNS 200 μg BID, 200 μg QD and placebo.

Nasal congestion/obstruction, rhinorrhea, postnasal drip, loss of smell scores and peak nasal inspiratory flow (PNIF) were recorded daily. Adults with bilateral polyposis and AM nasal congestion at least moderate during placebo run-in were enrolled. Polyp size was graded by nasal endoscopy. Primary endpoints were changes in polyp size score at endpoint and congestion score over month1.

Study #1: Polyp size decreased with MFNS 200 mg BID (27%, p=0.011) and MFNS 200 mg QD (33%, p<0.001) versus placebo (17%). All symptoms and PNIF improved consistently and significantly over month1 with both MFNS regimens. Study #2: Polyp size decreased numerically with MFNS 200 mg BID (25%, p=0.078) versus placebo (16%). Congestion improved with both MFNS regimens (BID, 29% [p<0.001]; QD, 20% [p=0.01]) versus placebo (8%) at month1. MFNS 200 mg BID significantly improved PNIF and all symptoms; MFNS 200 mg QD significantly improved PNIF and anterior rhinorrhea. In both studies, MFNS 200 mg BID was significantly better than MFNS 200 mg QD on congestion/obstruction over month1 and on percent of responders. A low incidence of side effects was seen, the most common being epistaxis, URI and headache.

MFNS 200 μg BID has demonstrated activity in the treatment of nasal polyposis.