ABC
1Main
2Brand NameRelovair (fka Beyond Advair, HORIZON), fka 444, 698
3Generic Namefluticasone furoate, vilanterol trifenatate
4MechanismInhaled corticosteroid and LABA combination
5Note that fluticasone propionate is the steroid in Advair and Flonase. Fluticasone furoate is a different steroid, which is Veramyst.
6AdministrationOnce-daily inhalation
7EconomicsTHRX
8DeviceSingle step activation inhaler
9Clinical Trials
10Phase III Relovair 100/25mcg against fluticasone furoate 100mcg in uncontrolled asthma patients
11Time to first severe asthma exacerbation is the primary endpoint.
12
13Phase III Relovair versus Advair 24-week study
14
15Phase III fluticasone furoate versus fluticasone propionate versus placebo
16
17Phase III COPD n=1560
18Three doses of FF combined with 25mcg of 444 versus 444 monotherapy dosed once daily.
19
20961081 Phase IIB COPD - Initiated 12/21/10
21n=425 100mcg, 400mcg, 800mcg QD and 100mcg, 200mg and 400mcg BID versus 50mcg salmterol versus placebo in DISKUS.
22
23642444 - Phase 2B started 12/07 - "HORIZON" '444 is the LABA n=600 asthma
24New inhaler used.
25
26685698 - Phase 2B started 12/07 - "HORIZON" 698 is the steroid n=1800
27New inhaler used.
28Showed dose curve of no response at 25mcg with toxicity of urinary cortisol reduction at 800mcg.
29
30685698 - Phase II in Asthma, started 10/08 n=750
31qd and bid tested.
32
33705/244 Phase II COPD study
34
35698/444 combination study.
36
37698/444 Phase III study
38
39159797 - qd beta2 agonist - asthma & COPD in combination with a glucocorticoid agonist
40159802 - LABA beta2
41799943, 685698 - glucocorticoid agonist
42698 efficacious in phase 2
43233705/642444
44573719/vilanterol - Combiation LAMA/LABA in Phase III
45961081 - muscarinic antagonist and a beta2receptor agonist.