Study No Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objectives: Study Endpoints: Pharmacokinetics:

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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No: VRX-RET-E Title: A Randomized, Partially Double-Blind, Four-Way Crossover Study to Determine the Effects of a Single Dose of Retigabine Combined with a Single Dose of Alcohol. Rationale: In preclinical studies, the interaction of retigabine with a subhypnotic dose of ethanol was examined in mice. A slight but not significant potentiation of ethanol s effects was observed after administration of 30 and 100mg/kg of retigabine. Therefore, an interaction between retigabine and ethanol in humans was considered possible. The effects of each drug on the pharmacokinetic (PK) parameters of the other were investigated along with pharmacodynamic endpoints. Phase: I Study Period: 14 January February 2008 Study Design: Randomized, partially double-blind, 4-way crossover study. This study consisted of 3 periods: a screening/qualifying period, a treatment period, and a post-treatment follow-up period. The screening/qualifying period lasted up to 56 days and consisted of a screening session and one 2-night double-blind inpatient qualifying session. The treatment period consisted of four 2-night inpatient treatment sessions. The washout period between treatment dosing was 5 to 21 days. The post-treatment follow-up period was conducted between 3 and 14 days after the last dose of study drug or at the time of premature withdrawal and consisted of safety assessments. Centers: One center in Canada Indication: None. Treatment: Ethanol 1g/kg body weight (Absolut Vodka, 40% ethanol [approximately 5.28 Units (USA), and 9.38 Units (UK)] and ethanol placebo were each administered once and consumed in 20 min during the qualifying period. Two retigabine 100mg tablets or retigabine placebo tablets were each administered orally as single doses two times, in combination with ethanol 1.0g/kg body weight (Absolut Vodka, 40% ethanol) or in combination with placebo ethanol (light apple juice), with a washout period of 5 to 21 days between doses. The following treatments were administered during the qualifying period: Qualification Treatment A: Ethanol beverage (1.0 g/kg) Qualification Treatment B: Ethanol placebo beverage (light apple juice) The following treatments were administered during the treatment period in a randomized manner: Treatment A (retigabine alone): Retigabine 200 mg + ethanol placebo beverage (light apple juice) Treatment B (ethanol alone): Retigabine placebo + ethanol beverage (1.0 g/kg) Treatment C (retigabine + ethanol): Retigabine 200 mg + ethanol beverage (1.0 g/kg) Treatment D (placebo): Retigabine placebo + ethanol placebo beverage (light apple juice) Objectives: The objective was to determine the safety, tolerability, and pharmacokinetic (PK) effects when retigabine 200mg was combined with an intoxicating dose of ethanol (1.0g/kg). An additional objective was to evaluate the pharmacodynamic () effects of combining retigabine (200mg) with an intoxicating dose of ethanol (1.0g/kg). Study Endpoints: Pharmacokinetics: The following PK parameters were determined for retigabine and ethanol: maximum plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the concentration time curve from time zero to last assessment [AUC(0-t)], AUC from time zero to 8 hours [AUC(0-8)], AUC from time zero to infinity [AUC(0- )], apparent clearance (CL/F), terminal elimination rate (λz), terminal half-life (t½), and apparent volume of distribution (V/F). Pharmacodynamics: The following measures were analyzed: Visual analogue scales (VASs) (Dizziness, Feel Sick, Nausea, Intoxication, Vision, and Attention), Balance platform, Choice reaction time (CRT), and Divided Attention Test (DA). Safety: Monitoring of adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), physical examination, clinical laboratory tests. Clinical laboratory test, vital signs, and ECG results are not reported in this summary. Statistical Methods: The PK Population included all subjects who completed the study. PK parameters were determined for all complete profiles. The safety population included all subjects who received at least one dose of study drug in the treatment period. The population included all subjects who completed all treatment sessions and who 1

2 had no major protocol violations that would exclude the subject from analysis, and those who had valid data. Pharmacokinetics: The primary parameters of interest for the statistical analysis to evaluate the effect of ethanol on the PK profile of retigabine were AUCs and Cmax of retigabine. A linear mixed-effect analysis of variance (ANOVA) was performed on the log to the base e-transformed Cmax and AUCs to evaluate the treatment effect on the PK parameters. The model included the treatment sequence, period, and treatments as fixed effects, and the subject within the treatment sequence as a random The least squares means, their difference with standard errors and 90% confidence interval (CI) were estimated from this analysis. The limits of the confidence intervals were retransformed using antilogarithms to obtain 90% CIs for the ratio of the mean PK parameters of retigabine with ethanol and placebo. Pharmacodynamics: Where longitudinal measurements were taken, the following summary parameters were calculated: The peak effect (Emax or Emin), the time of peak effect (TEmax) The area under the effect curve to 2 hours (AUE(0-2h)) The area under the effect curve to 8 hours (AUE(0-8h)) The area under the effect curve to 24 hours (AUE(0-24h)) For Balance platform assessment the following outcome measures were calculated: Length of the path of the center of pressure (COP) coordinates (cm); eyes open Length of the path of the COP coordinates (cm); eyes closed Area of a 95% confidence ellipse (cm 2 ); eyes open Area of a 95% confidence ellipse (cm 2 ); eyes closed Average velocity of the COP (cm/sec); eyes open Average velocity of the COP (cm/sec); eyes closed Total test time (seconds) Total test time was calculated to determine validity of each test, but not analyzed further. For CRT the following measures were analyzed: TRT (msec) RRT (msec) MRT (msec) Percentage correct responses For DA the following outcome measures were used to assess performance on this task: Mean root mean square (RMS) distance: the RMS distance from the center of the road (pixels) Mean percentage over road: percentage of time over the road (%) Mean greatest distance: the maximum distance from the center of the road (pixels) Mean response latency of correct responses (msec) Number of false alarms Percentage of target hits (%) An endpoint was defined as any of these summary statistics calculated for any of the pharmacodynamic measures. The comparisons of interest were as follows: ethanol alone vs. placebo retigabine alone vs. placebo retigabine + ethanol vs. ethanol alone retigabine alone vs. retigabine + ethanol The within-subject differences were to be calculated for each subject for each endpoint and these data were listed and summarized using standard summary statistics, including the 95% prediction interval. A linear mixed model was fit to each endpoint. The cell means for this model were calculated with their associated 95% CIs. The contrasts of interests were extracted from this model and their point estimates and associated 95% CIs were calculated. Safety: Summary statistics were calculated for safety data. Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA ) Version 9.1, and summarized in frequency tables. Study Population: Healthy male and female subjects between 19 and 55 years of age, who were moderate alcohol drinkers, defined as having 7 to 28 standard drinks per week and having consumed at least 5 standard drinks on at least one occasion in the preceding month. One standard alcoholic drink is equivalent to 1.5 oz hard liquor or 5 oz wine or 12 oz beer. 2

3 Number of Subjects: Total Planned, N 24 Qualifying Period 1 (subjects received ethanol or placebo), N 48 Dosed, N 24 Safety Population, n (%) 24 (100%) PK Population, n (%) 17 (71%) Population, n (%) 17 (71%) Completed, n (%) 19 (79%) Total Number Subjects Withdrawn n (%) 5 (21%) Withdrawn due to Adverse Events n (%) 0 Withdrawn for Other Reasons n (%) 5 (21%) Demographics Total N (Safety Population) 24 Females: Males 4: 20 Mean Age in Years (SD) 38.5 (8.51) Mean Weight in Kg (SD) 78.8 (7.50) White n (%) 16 (67) 1. Of the 48 subjects who were randomized and received at least one dose of ethanol or placebo in the qualifying period; 35 were considered eligible and 13 failed the qualifying criteria. Twenty-four eligible subjects were randomized to the treatment period and received at least one dose of study drug Note: Percentage was calculated based on the number of subjects randomized as the denominator. 3

4 Pharmacodynamics () Endpoints: Summary of Analysis for Visual Analogue Scales Population Attention Span Good Emin (-38.9, -7.0) (-29.9, 2.0) (-29.3, 2.5) 22.4 (6.5, 38.3) AUE(0-2h) (-47.4, -6.4) (-32.0, 9.0) (-32.7, 8.1) 27.7 (7.3, 48.2) AUE(0-8h) (-153, -13.1) (-105, 35.9) (-117, 23.3) 95.7 (25.6, 166) AUE(0-24h) -103 (-188, -19.2) (-116, 53.1) (-150, 18.1) (54.1, 222) Dizziness Emax 37.0 (14.6, 59.4) 10.1 (-12.2, 32.4) -0.7 (-22.6, 21.1) (-48.1, -4.2) AUE(0-2h) 38.6 (16.0, 61.1) 9.4 (-13.0, 31.8) -3.3 (-25.3, 18.6) (-47.9, -3.9) AUE(0-8h) (55.8, 216) 27.7 (-51.7, 107) 2.1 (-75.7, 79.8) -110 (-188, -32.1) AUE(0-24h) (53.9, 242) 24.2 (-69.3, 118) 34.4 (-57.1, 126) -158 (-250, -66.3) Feel Sick Emax 13.5 (-1.1, 28.0) 4.6 (-10.0, 19.1) 7.2 (-7.4, 21.8) (-30.8, -1.5) AUE(0-2h) 7.1 (-5.8, 20.0) 3.8 (-9.1, 16.6) 11.5 (-1.4, 24.4) (-27.8, -1.8) AUE(0-8h) 42.5 (-18.7, 103.7) 9.1 (-52.0, 70.2) 42.6 (-18.8, 103.9) (-137.6, -14.2) AUE(0-24h) 46.5 (-30.0, 122.9) 3.1 (-73.2, 79.4) 56.3 (-20.3, 133.0) (-176.8, -22.7) Intoxication Emax 51.5 (34.3, 68.8) 2.3 (-14.8, 19.3) 9.6 (-6.8, 26.1) (-75.4, -42.3) AUE(0-2h) 76.0 (46.6, 105.4) 0.7 (-28.3, 29.7) -3.6 (-31.7, 24.4) (-99.8, -43.4) AUE(0-8h) 240 (147, 333) 6.5 (-85.4, 98.4) 14.3 (-74.5, 103.0) -248 (-337, -159) AUE(0-24h) 258 (153, 362) 7.3 (-95.8, 110) 46.3 (-53.3, 146) -297 (-397, -197) Nausea Emax 13.3 (-0.7, 27.4) 4.7 (-9.4, 18.9) 13.8 (-0.2, 27.9) (-36.7, -8.2) AUE(0-2h) 10.6 (-5.8, 27.0) 0.1 (-16.4, 16.5) 12.9 (-3.4, 29.2) (-39.9, -6.8) AUE(0-8h) 35.7 (-24.1, 95.5) 3.6 (-56.4, 63.7) 46.1 (-13.4, 105.7) (-139, -17.8) AUE(0-24h) 49.0 (-25.5, 123.4) 1.8 (-73.0, 76.5) 56.9 (-17.3, 131.1) (-179, -28.9) Intoxication Vision Clear, Crisp Emin (-38.6, 9.6) (-50.6, -2.3) (-45.1, 2.6) 9.3 (-14.6, 33.2) AUE(0-2h) (-42.3, -4.9) (-30.3, 7.2) (-37.0, 0.0) 30.5 (12.0, 49.1) 1 AUE(0-8h) (-144, -3.4) (-115, 25.9) (-124, 15.3) 83.4 (13.6, 153) 1 AUE(0-24h) (-161, 23.0) (-120, 64.7) -108 (-199, -16.7) (57.9, 241) 1 4

5 Summary of Analysis for Balance Platform, Eyes Open Population 95% Confidence Ellipse Area, cm 2 Emax (cm 2 ) 7.27 (1.87, 12.7) (-6.11, 4.78) 3.70 (-1.67, 9.06) (-17.1, ) AUE(0-2h) 7.55 (3.38, 11.7) (-4.62, 3.80) 1.97 (-2.16, 6.11) (-14.1, -5.73) AUE(0-8h) 24.2 (10.7, 37.8) (-16.8, 10.6) 2.61 (-10.8, 16.1) (-43.6, -16.3) AUE(0-24h) 31.1 (14.2, 48.0) (-20.2, 14.1) (-18.3, 15.7) (-50.2, -15.5) Mean COP Velocity, cm/sec Emax (cm/sec) 0.52 (0.30, 0.75) 0.02 (-0.20, 0.25) 0.06 (-0.17, 0.28) (-0.780, -0.33) AUE(0-2h) 0.69 (0.47, 0.90) 0 (-0.21, 0.22) 0.04 (-0.180, 0.25) (-0.94, -0.51) AUE(0-8h) 1.60 (0.92, 2.28) (-0.83, 0.53) 0.27 (-0.41, 0.95) (-2.70, -1.34) AUE(0-24h) 2.23 (0.97, 3.49) (-1.53, 0.99) 0.33 (-0.96, 1.61) (-4.11, -1.54) COP Path Length, cm Emax (cm) 31.4 (17.9, 44.8) 1.58 (-11.8, 15.0) 3.44 (-9.98, 16.9) (-46.7, -19.8) AUE(0-2h) 41.2 (28.3, 54.1) 0.18 (-12.7, 13.1) 2.20 (-10.7, 15.1) (-56.2, -30.3) AUE(0-8h) 96.0 (55.1, 137) (-49.4, 32.1) 16.4 (-24.4, 57.2) (-162, -80.1) AUE(0-24h) 134 (58.4, 210) (-90.8, 61.0) 20.2 (-57.1, 97.4) -170 (-247, -92.0) Summary of Analysis for Balance Platform, Eyes Closed Population 95% Confidence Ellipse Area (cm 2 ) Emax (cm 2 ) 14.1 (5.22, 22.9) (-9.08, 8.57) 5.50 (-3.36, 14.4) (-28.7, -11.0) AUE(0-2h) 12.2 (3.95, 20.5) (-8.21, 7.91) 5.51 (-2.81, 13.8) (-26.0, -9.79) AUE(0-8h) 34.9 (11.2, 58.7) (-25.4, 22.1) 11.0 (-12.9, 34.8) (-71.3, -23.7) AUE(0-24h) 37.4 (13.0, 61.7) (-31.7, 17.1) 3.49 (-21.1, 28.1) (-72.6, -23.7) Mean COP Velocity, cm/sec Emax (cm/sec) 0.97 (0.38, 1.56) 0.27 (-0.32, 0.86) (-0.70, 0.47) (-1.18, -0.00) AUE(0-2h) 0.91 (0.40, 1.42) 0.15 (-0.35, 0.65) 0.17 (-0.34, 0.68) (-1.43, -0.43) AUE(0-8h) 2.39 (1.26, 3.52) 0.22 (-0.91, 1.35) (-1.40, 0.85) (-3.02, -0.76) AUE(0-24h) 2.85 (1.32, 4.38) 0.46 (-1.07, 1.99) 1.02 (-0.50, 2.54) (-4.94, -1.88) COP Path Length, cm Emax (cm) 58.4 (23.1, 93.7) 16.3 (-18.9, 51.5) (-41.8, 28.5) (-70.7, -0.23) AUE(0-2h) 54.7 (23.9, 85.4) 8.82 (-21.1, 38.8) 10.0 (-20.6, 40.6) (-85.9, -25.9) AUE(0-8h) 143 (75.4, 211) 13.4 (-54.2, 80.9) (-83.6, 51.2) -114 (-181.3, -46.1) AUE(0-24h) 170 (78.6, 262) 27.3 (-64.1, 119) 61.6 (-29.4, 153) -205 (-296, -113) Summary of Analysis for Choice Reaction Time Population Total Reaction Time, ms Emax (msec) 140 (84.8, 196) 38.7 (-16.4, 93.8) (-69.7, 40.0) (-142, -31.6) 1 AUE(0-2h) 213 (124, 302) 86.3 (-2.4, 175) (-117, 59.9) (-186, -9.2) 1 AUE(0-8h) 667 (386, 948) 206 (-73.7, 485) -130 (-408, 148) -331 (-610, -52.3) 1 AUE(0-24h) 1185 (530, 1841) 485 (-168, 1138) -340 (-988, 309) -361 (-1011, 289) 5

6 Recognition Reaction Time, ms Emax (msec) 50.2 (25.7, 74.6) 18.7 (-5.7, 43.1) -1.6 (-25.9, 22.7) (-54.3, -5.5) AUE(0-2h) 87.6 (53.0, 122) 32.9 (-1.6, 67.4) (-46.4, 22.3) (-77.1, -8.1) AUE(0-8h) 277 (160, 396) 103 (-15.0, 220) (-161, 73.1) -131 (-249, -13.4) AUE(0-24h) 498 (219, 778) 251 (-27.9, 530) -141 (-418, 136) -106 (-385, 172) Motor Reaction Time, ms Emax (msec) 93.7 (59.7, 128) 20.0 (-13.8, 53.8) (-48.8, 18.5) (-92.3, -24.8) AUE(0-2h) 124 (65.4, 183) 52.6 (-6.1, 111) (-74.5, 42.4) (-114.3, 2.9) AUE(0-8h) 386 (206, 566) 99.7 (-79.1, 279) (-262, 93.8) -202 (-381, -23.6) AUE(0-24h) 672 (276, 1069) 218 (-176, 613) -192 (-584, 199) -262 (-655, 131) Percent Correct Responses Emin (msec) (-5.16, 0.06) (-2.98, 2.20) 1.10 (-1.48, 3.69) 1.06 (-1.54, 3.66) AUE(0-2h) (-5.00, -0.16) (-3.53, 1.29) 0.33 (-2.08, 2.73) 1.13 (-1.28, 3.55) AUE(0-8h) (-17.7, -1.29) 1.03 (-7.15, 9.21) 5.69 (-2.46, 13.9) 4.86 (-3.34, 13.1) AUE(0-24h) (-41.5, 21.8) (-38.1, 24.9) 14.5 (-170, 45.9) (-42.8, 20.4) 6

7 Summary of Analysis for Divided Attention Test, Mean Hit Latency, Percentage Over Road and Percentage Target Hits Population Mean Root Mean Square (pixels) Distance Emax 0.91 (-0.49, 2.31) (-1.57, 1.29) (-1.61, 1.18) (-2.28, 0.62) AUE(0-2h) (14.6, 37.0) (-13.20, 9.52) 0.01 (-11.1, 11.1) (-39.1, -16.2) AUE(0-8h) 68.5 (190, 118) (-64.6, 35.7) 23.3 (-26.0, 72.6) (-157, -55.7) AUE(0-24h) 68.2 (12.4, 124) (-76.1, 37.5) 27.4 (-28.1, 82.9) (-172, -57.7) Mean % Over Road Emin (-24.2, -13.9) (-5.93, 4.62) (-5.46, 4.83) 18.7 (13.4, 24.0) AUE(0-2h) (-33.9, -18.8) (-7.80, 7.55) 1.27 (-6.27, 8.80) 24.9 (17.2, 32.7) AUE(0-8h) (-106.5, -49.2) 6.54 (-22.5, 35.6) (-33.1, 23.9) 89.0 (59.6, 118) AUE(0-24h) (-122, -36.3) 5.83 (-37.9, 49.6) (-47.4, 37.4) 89.8 (45.4, 134) Mean Greatest Distance (pixels) Emax 58.4 (36.4, 80.5) 0.34 (-21.7, 22.4) 13.8 (-8.13, 35.8) (-94.3, -49.6) AUE(0-2h) 89.9 (58.7, 121) (-35.8, 26.7) 4.39 (-26.7, 35.5) (-131, ) AUE(0-8h) 263 (138, 388) (-166, 84.1) 31.7 (-92.7, 156.2) -335 (-462, -209) AUE(0-24h) 214 (21.1, 407) (-264, 122) 162 (-30.2, 354) -447 (-642, -251) Mean Hit Latency (ms) Emax 106 (81.9, 130) -5.3 (-29.4, 18.9) (-38.4, 9.6) (-121, -72.7) AUE(0-2h) 165 (123, 208) (-69.1, 16.1) (-72.9, 11.8) -161 (-203, -119) AUE(0-8h) 503 (403, 602) 20.5 (-80.3, 121) (-187, 12.4) -395 (-495, -295) AUE(0-24h) 435 (159, 711) 41.7 ( ) -159 (-435, 118) -234 (-510, 41.3) Number of False Alarms Emax 3.2 (0.9, 5.6) 0.8 (-1.6, 3.1) -0.2 (-2.6, 2.2) -2.3 (-4.6, 0.1) AUE(0-2h) 2.0 (-0.6, 4.6) 0.4 (-2.2, 3.0) 0.2 (-2.4, 2.8) -1.8 (-4.4, 0.8) AUE(0-8h) 8.3 (-2.7, 19.4) -3.7 (-14.7, 7.3) 0.4 (-10.8, 11.7) (-23.5, -1.5) AUE(0-24h) 16.0 (-5.4, 37.3) 11.3 (-9.9, 32.4) -0.3 (-21.9, 21.3) -4.4 (-25.6, 16.8) % Target Hits Emin (-26.8, -8.95) (-9.87, 7.77) 7.51 (-1.32, 16.3) 9.29 (0.47, 18.1) AUE(0-2h) (-30.6, -8.31) (-11.5, 10.7) 8.71 (-2.36, 19.8) 10.3 (-0.75, 21.4) AUE(0-8h) (-95.4, -26.4) (-39.6, 28.5) 10.8 (-23.2, 44.9) 44.5 (10.5, 78.5) AUE(0-24h) (-125, -5.33) (-96.7, 21.0) 8.90 (-50.0, 67.8) 18.5 (-40.2, 77.2) Pharmacokinetics (PK) Endpoints: Comparison of Retigabine Pharmacokinetic s Between Retigabine Alone and Retigabine + Ethanol PK Population Least Squares Mean (90% Confidence Interval) PK (Unit) Retigabine Alone Retigabine + Ethanol Ratio of to RTG Alone Cmax (ng/ml) (467.5, 605.2) (573.4, 742.4) 1.23 (1.02, 1.47) AUC(0-t) (h*ng/ml) (2480.5, ) (3388.7, ) 1.37 (1.27, 1.47) AUC(0-8h) (h*ng/ml) (1713.2, ) (2245.0, ) 1.31 (1.18, 1.46) AUC(0- ) (h*ng/ml) (2703.8, ) (3673.6, ) 1.36 (1.29, 1.43) Note: Least squares means were estimated from a linear mixed-effect ANOVA on the log to the base e transformed parameters with treatment sequence, period and treatment as fixed effects, and subject within treatment sequence as a random Values were then exponentiated to obtain the LS Means of the estimates and confidence intervals. 7

8 Summary of Ethanol Pharmacokinetic s for and Ethanol + Retigabine PK Population Geometric Mean (%Coefficient of Variation) PK (Unit) N=17 Retigabine + Ethanol N=17 Cmax (mmol/l) (15.4) (13.2) Tmax (h) (45.0) (34.6) AUC(0-8h) (h*mmol/l) (7.2) (8.0) AUC(0-t) (h*mmol/l) (7.3) (8.6) Safety results: Treatment-emergent adverse events (TEAEs) were defined as those adverse events occurring during the treatment period. Adverse events that occurred in more than one subject in any group are presented below. Treatment-Emergent RTG Alone Adverse Events: N (Safety Population) No. subjects with AEs, n (%) 3 (14%) 13 (62%) 8 (40%) 18 (75%) Feeling drunk 0 12 (57%) 0 15 (63%) Somnolence 2 (9%) 5 (24%) 5 (25%) 3 (13%) Headache 0 4 (19%) 1 (5%) 5 (21%) Euphoric mood 0 1 (5%) 0 3 (13%) Dizziness 0 1 (5%) 1 (5%) 2 (8%) Nausea (10%) 0 Note: Percentage was calculated based on the number of randomized subjects per group who received the study drug as the denominator. Subjects were counted only once per system organ class or preferred term. Serious Adverse Events: No deaths or serious adverse events occurred in the study. 8

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