A	B	C
1	Main
2		Brand Name	MK-974, MK-0974
3		Generic Name	telcagepant
4		Commentary	GSK executive notes efficacy not on par with triptans.
5		Indication	Migraines
6		Mechanism	Calcitonin-gene related peptide (CGRP) antagonist. Also inhibits vasodilation. CGRP binds to the trigeminal nerve.
7		Timeline	2009 NDA filing, potentially Q1. File in 2011.
8		Competition	Triptans, which have cardiovascular side effects (activate vasoconstriction), dizziness, paraesthesia, throat tightness and chest discomfort. Olcegepant
9		PK	Modified pill vs gel to delay launch.
10		Safety	Liver enzyme elevations - Only 3 in one phase 3 but cancelled backup program for liver enzyme problems.
11		Clinical Trials
12			Phase III
13			140mg and 280mg more effective than placebo.
14			3 patients had 3x liver enzyme elevation.
15
16			Phase III vs Zomig - Will be presented at American Headache Society June 26 2008 - Published Lancet 2008
17			n=1380 with moderate-to-severe acute migraine attack. 150mg, 300mg vs 5mg Zomig vs placebo.
18			300mg 2H endpoint vs Zomig was 0.83 (slightly inferior), wheras 2H-24H sustained relief endpoint was 1.18 (slightly superior).
19			26.9% pain free at 2H vs 31.3% for Zomig vs. 9.6% for placebo.
20			55.0% pain relief at 2H vs. 56.4% for Zomig vs. 27.7% for placebo.
21			20.2% pain freedom 2-24H vs. 18.2% for Zomig vs. 5.0% for placebo.
22			Dry mouth, vomiting and fatigue > placebo but low overall. 31% AE for 150mg, 37% for 300mg, 51% for 5mg and 32% for placebo.
23			Lancet editorial.
24			Lancet paper.
25
26			Phase II dose-ranging 25mg to 600mg
27			Comparable efficacy to Maxalt with no CV safety issues.