A	B	C	D
1	Main
2		Brand Name	Tyvaso (Inhaled Remodulin, fka Viveta)
3		Generic Name	inhaled treprostinil
4		Indication	PAH (pulmonary arterial hypertension)
5		Competition	Flolan, Revatio or Tracleer have about 20,000 users combined
6		Price	3% on July 1st, Flolan charges 75-80K annualy, because remodulin will have a higher efficacy rate, 80K + premium= 90K a year
7		PK	Less D/D vs Revatio.
8		IP	2017 COM: 5859006 ???, 5153222, 6521212, 6756033, 6765117.
9		Mechanism
10		Market	Flolan transition patients start on higher doses of IV Remodulin
11		Clinical Trials
12
13			TRIUMPH I - n=235 - Successful outcome presented at ATS 2008
14			SS benefit in 6MWD at week 12 p<0.0006. 20m change from baseline. If mean improvement was used, p=0.09 (+14m at 12 weeks).
15			Benefits of inhaled remodulin: intravenous therapy is prone to catheter-related infections, drug tolerance, and major systemic side effects.
16
17
18			Favorable Effects of Inhaled Treprostinil in Severe Pulmonary Hypertension
19			n= 123 broken up into three groups -- Primary endpoint - change in PVR (pulmonary vascular resistance)
20			1. randomized crossover-design study (44 patients) vs iloprost
21				average mm hg - dosed at 7.5 μg
22				comparable PVR decrease, with a significantly different time course (p < 0.001),
23				treprostinil showing a more sustained effect on PVR (p < 0.0001) and fewer systemic side effects
24			2. Dose escalation Study (31 patients)
25				3 H duration - A near-maximal acute PVR decrease was observed at 30 μg treprostinil
26			3. study of reduction of inhalation time while keeping the dose fixed (48 patients).
27				A dose of 15 μg treprostinil was inhaled with 18, 9, 3, 2 pulses, or 1 pulse, each mode achieving comparable,
28				sustained pulmonary vasodilation without significant side effects.
29
30
31
32
33
34			effect of PAH on exertion
35			increase of CO when walking + remodulen increase of output
36			whn will this walk take place (right after administration)?