A	B	C	D	E	F	G	H	I	J	K	L	M	N	O	P	Q	R	S	T	U	V	W	X	Y	Z	AA	AB	AC	AD
1	Main
2		Brand Name	Topamax
3		Generic Name	topiramate
4		Mechanism	Blocks voltage-dependent sodium channels, augments GABA, antagonizes AMPA/kainate subtype of glutamate receptor, inhibits carbonic anhydrase enzyme (isozymes II and IV) MW 339.
5		Pharmacokinetics	Peak plasma within 2 hours. Relative bioavailability of 80%. PK linear. Plasma elimination half-life is 21 hours. 70% excretion in urine, unmetabolized.
6		Administration	Oral
7		Label	Epilepsy, Migraine
8		Clinical Studies	n=487 epilepsy who had 1-2 well-documented seizures during 3-month baseline phase. 400mg vs 50mg KM curve was p=0.0002 in time to first seizure.
9			2 migraine studies. 26 weeks showed -1.1 for placebo vs -1.2, -2.1 and -2.4 for topamax 50,100 and 200mg.
10		IP	8/2008. 30-month stay expected to expire in 9/2006 for MYL. Will someone launch at risk? Cobalt expires 3/08.
11		Side Effects	Metabolic acidosis, myopia, glaucoma, oligohidrosis, hyperthermia, cognition dysfunction, psychiatric disturbances, somnolence or fatigue
12		Efficacy	Responder rates around 40% in 6 epilepsy studies vs 0-20% for placebo. Response rate is % of patients with at least a 50% reduction.
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18			1Q02	2Q	3Q	4Q	1Q03	2Q	3Q	4Q	1Q04	2Q	3Q	4Q	1Q05	2Q	3Q	4Q	1Q06	2Q	3Q	4Q	1Q07	2Q	3Q	4Q	1Q08
19		Topamax (8/2008)	117	109	143	159	181	205	192	226	254	257	287	293	310	334	327	319	373	393	435	429	501	472	498	535	520
20		International	32	39	41	47	50	58	60	70	75	78	79	88	96	97	102	94	98	102	98	100	109	106	115	117	126
21		Worldwide	149	148	184	206	231	263	252	296	329	335	366	381	406	431	429	413	471	495	533	529	610	578	613	652	646	0	0	0
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23			2001	2002	2003	2004	2005	2006	2007	2008	2009	2010	2011	2012	2013	2014	2015
24		Topamax (8/2008)	358.3	528	804	1091	1290	1630	2006	2306.8999999999996
25		International	119	159	238	320	389	398	447	514.05
26		Worldwide	477.3	687	1042	1411	1679	2028	2453	2820.95	0	0	0	0	0	0	0
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28		USA		0.47362545353056085	0.5227272727272727	0.35696517412935314	0.18240146654445466	0.26356589147286824	0.23067484662576687		0.33832668417171274
29		International		0.3361344537815125	0.4968553459119496	0.34453781512605053	0.21562499999999996	0.023136246786632286	0.12311557788944727		0.2565674065825987
30		WW		0.4393463230672532	0.5167394468704511	0.3541266794625719	0.18993621545003547	0.2078618225134008	0.20956607495069024