Efficacy

Reduction in pain12

Pain reduction as early as Week 11

ADP score reduction for GRALISE was -2.1 vs -1.6 with placebo (P=0.013).2

Statistically significant pain reduction vs placebo beginning Week 1 and continuing throughout 10-week study.2

With its unique gastroretentive technology and 900 mg strength option, patients can achieve the optimal daily dose of 1800 mg with just 2 tablets.3

GRALISE vs placebo over 10 weeks2

Chart

Study design:

Patients from 89 investigative sites participated in this randomized, double-blind, parallel design, placebo-controlled, multicenter clinical trial. The study period included a 1-week baseline period, followed by randomization and a 2-week titration to a once-daily dose of 1800 mg G-GR or matched placebo, followed by an 8-week maintenance-dose period, followed by a 1-week dose-tapering period. Four hundred fifty-two (452) patients were randomized, with 221 receiving 1800 mg of GRALISE and 231 receiving placebo.2

Primary endpoint:

Change in baseline observation carried forward (BOCF) average daily pain score from Baseline to Week 10 of the efficacy treatment period.2

ADP=Average daily pain.

Efficacy: Secondary Endpoints

More patients reported feeling “much” or “very much” improved with GRALISE vs placebo2

Patient and Clinical Global Impression of Change (%)2

Chart

Study design:

Patients from 89 investigative sites participated in this randomized, double-blind, parallel design, placebo-controlled, multicenter clinical trial. The study period included a 1-week baseline period, followed by randomization and a 2-week titration to a once-daily dose of 1800 mg G-GR or matched placebo, followed by an 8-week maintenance-dose period, followed by a 1-week dose-tapering period. Four hundred fifty-two (452) patients were randomized, with 221 receiving 1800 mg of GRALISE and 231 receiving placebo.2

Primary endpoint:

Change in baseline observation carried forward (BOCF) average daily pain score from Baseline to Week 10 of the efficacy treatment period.2

~43%reduction

GRALISE provided an approximate 43% reduction in sleep interference due to PHN pain vs an approximate 31% with placebo. Sleep interference was a secondary endpoint.24

~30%reduction

GRALISE reduced pain by half in
approximately 30% of PHN patients.2

GRALISE reduced sleep interference compared with placebo (-2.3 vs -1.59, respectively [P=0.0001]) and this improvement persisted throughout the 10-week duration of the study. Because of the sequential hierarchical paradigm, these comparisons were not considered statistically significant.

References:

  1. Argoff CE, Chen C, Cowles VE. Clinical development of a once-daily gastroretentive formulation of gabapentin for treatment of postherpetic neuralgia: an overview. Expert Opin Drug Deliv. 2012;9(9):1147-1160.
  2. Sang CN, Sathyanarayana R, Sweeney M, et al. Gastroretentive gabapentin (G-GR) formulation reduces intensity of pain associated with postherpetic neuralgia (PHN). Clin J Pain. 2013;29(4):281-288.
  3. GRALISE. Prescribing information. Almatica Pharma LLC; 2023.
  4. Data on file. Almatica Pharma LLC; 2009.
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Most patients pay as little as $20*

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*Applies to commercially insured patients. Individual costs may vary. Program eligibility and restrictions apply.

Gabapentin is a controlled substance in several states. Contact local authorities for more information. Advise patients to take GRALISE only as prescribed.