Innovation Pharmaceuticals Inc (IPIX)

[F1ash]

"any idea if foam formulations (vs liquid) could possibly cut down on the number of required applications? from say 1/day to possibly every other day... "



Easier applications but not necessarily less frequent. "Retention" is the tough part of the enemas I imagine.

"Methods
Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo.

Results
Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo (Study 1: 38.3% vs 25.8%; P = .0324; Study 2: 44.0% vs 22.4%; P < .0001). A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution (Study 1: 46.6% vs 28.0%; P = .0022; Study 2: 50.0% vs 28.6%; P = .0002) and endoscopic improvement (Study 1: 55.6% vs 43.2%; P = .0486; Study 2: 56.0% vs 36.7%; P = .0013) at week 6. Most adverse events occurred at similar frequencies between groups, although events related to changes in cortisol values were reported more frequently with budesonide foam. There were no cases of clinically symptomatic adrenal insufficiency.



"In conclusion, budesonide rectal foam 2 mg twice daily for 2 weeks and then once daily for 4 weeks was generally well tolerated and was superior to placebo in inducing remission in patients with active, mild to moderate UP and UPS. The dosage form allows for targeted delivery to the affected areas of the rectum/sigmoid colon in patients with distal forms of UC and allows for reduction from a 2-week phase of twice-daily dosing to a 4-week phase of once-daily dosing, reducing the potential for systemic steroid-related adverse effects"

http://www.sciencedirect.com/science/article/pii/S0016508515001547