Gabapentin enacarbil extended release for the treatment of postherpetic neuralgia in adults

Figures & data

Table 1 Summary of published material showing common side effects of gabapentin enacarbil at varying doses

Adverse event	Placebo			600 mg/day			1,200 mg/day			2,400 mg/day			3,600 mg/day			4,800 mg/day			6,000 mg/day
Evidence source	A	B	C	A	B	C	A	B	C	A	B	C	A	B	C	A	B	C	A	B	C
n	245	95	31	163	–	–	269	107	–	–	82	8	–	87	8	–	–	8	–	–	8
CNS
Somnolence/sedation	6%	8%	0%	20%	–	–	27%	10%	–	–	11%	0%	–	14%	0%	–	–	13%	–	–	50%
Dizziness	4%	15%	3%	13%	–	–	22%	17%	–	–	26%	50%	–	20%	38%	–	–	75%	–	–	38%
Headache	11%	9%	3%	12%	–	–	15%	10%	–	–	10%	13%	–	7%	0%	–	–	25%	–	–	0%
Fatigue	4%	1%	0%	6%	–	–	7%	6%	–	–	4%	0%	–	10%	0%	–	–	0%	–	–	25%
GI
Nausea	5%	5%	6%	6%	–	–	7%	8%	–	–	4%	13%	–	9%	50%	–	–	13%	–	–	25%
Metabolism
Weight gain	2%	1%	–	2%	–	–	3%	3%	–	–	5%	–	–	5%	–	–	–	–	–	–	–

Notes: A = amalgamated data from three double-blind, placebo controlled 12 week trials in patients with RLS.¹⁷ B = randomized, double-blind, placebo controlled trial assessing efficacy and safety in patients with PHN.²⁰ C = randomized, double-blind, placebo controlled, cross over study in healthy volunteers.²⁴– indicates data unavailable. Data from¹⁷; data taken with permission from Zhang L, Rainka M, Freeman R, et al. A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of gabapentin enacarbil in subjects with neuropathic pain associated with postherpetic neuralgia (PXN I 10748). J Pain. 2013; l4(6):590–603;²⁰ and data taken with permission from Clinical Therapy, 31, Lal R, Sukbuntherng J, Luo W, et al, 1776–1786, copyright Elsevier (2009).²⁴

Abbreviations: CNS, central nervous system; GI, gastrointestinal; PHN, postherpetic neuralgia; n, number of patients; RLS, restless leg syndrome.

US Food Drug AdministrationHighlights of prescribing information: HORIZANT™ (gabapentin encarbil)Silver Spring, MDUS Food and Drug Administration2011 Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022399s000lbl.pdfAccessed May 19, 2013

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LalRSukbuntherngJLuoWPharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteersClin Ther20093181776178619808136

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