A	B	C
1	Main
2		Brand Name	Comfyde, fka RMJ333369
3		Generic name	carisbamate (S]-2-O-carbamoyl-1-o-chlorophenyl- ethanol)
4		Indication	Epilelpsy
5		Mechanism	Unknown, probably ion channel modulator. Felbamate derivative (had severe tox but was effective).
6		IP
7		Economics	Initially developed by SK Bio-Pharmaceuticals (NJ).
8		Timeline	Company preparing for end-of-p2 meeting with FDA. Looking to move into p3 results in the next few months.
9		PK	11.5-12.8 hour half life, 94% bioavailability. Fast titration.
10		Safety	QT shortening. Small % of liver toxicity.
11		Papers	Pharmacokinetics of carisbamate (RWJ-333369) in healthy Japanese and Western subjects. Zannikos et al. Epilepsia 1-10, 2009.
12		Competition	Lamictal (generic), Lamictal XR (GSK), Lyrica (PFE), Neurontin (generic), Topamax (generic).
13		Clinical Studies
14			Phase III "EPY-3013"
15			800mg and 1200mg/day 3-arm, 14-week study
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17			Phase III "EPY-3001" and "EPY-3002" - Bialer et al 2009
18			200mg unsuccessful and 400mg only successful once??
19			Two subsequent identically designed, randomized, double-blind, placebo-controlled Phase III studies examined
20			daily dosages of 200 and 400 mg. The 400 mg dosage was efficacious in one of the two studies, but the 200 mg dosage
21			did not separate from placebo in either study. An additional analysis of the efficacy of carisbamate in the presence and
22			in the absence of UGT-inducing AEDs revealed that, for both the 200 and 400 mg daily dosages in both of these studies,
23			noninduced subjects had a greater reduction in seizure rate and a greater responder rate than induced subjects.
24			Company ran three Phase III studies - R&D Day 2009 One Phase III failed as liver enzyme drug-drug interaction hurt efficacy.
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26			Phase III "EPY-3007" vs Topamax and levetiracetam
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28			Phase II NPP-2003 in DPN vs Lyrica
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30			Phase II Migraine prevention - n=323 - Cady et al Headache 2009
31			22 week study, 100mg, 300mg or 600mg vs placebo
32			No S.S. effect on migraine reduction.
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34			Phase IIB Epilepsy trial in n=537 refractory - Faught et al Neurology 2009
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55			6/06: JNJ notes top-line phase 2b results "completely validated what we hoped for".
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57			Less than placebo discontinuations at 100mg and 300mg.
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59			Phase IIA n=13 photosensitive patients - 2007 Trenite et al
60			Successful trial.