Efficacy: Primary Endpoint

Significant reduction in pain1,2

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

Pain reduction as early as Week 11

Significant pain reduction vs placebo beginning Week 1 and continuing throughout 10-week study2

GRALISE vs placebo over 10 weeks2

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. 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 the baseline week to Week 10 of the efficacy treatment period.2

ADP=average daily pain.

 

Efficacy: Secondary Endpoint

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

†This was not considered statistically significant.2

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs) including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

DRUG INTERACTIONS

An increase in gabapentin AUC values has been reported when administered with hydrocodone or morphine. It is recommended that GRALISE be taken at least 2 hours following antacid administration.

Efficacy: Secondary Endpoint

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

Patient and Clinician Global Impression of Change (%)2

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. 452 patients were randomized, with 221 receiving 1800 mg of GRALISE and 231 receiving placebo.2

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

Efficacy: Secondary Endpoint

GRALISE provided a 43% reduction in sleep interference due to PHN pain vs 31% with placebo.‡ Sleep interference was a secondary endpoint.2,3

‡This was not considered statistically significant.2

INDICATIONS AND USAGE

GRALISE is indicated for the management of postherpetic neuralgia (PHN). GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

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. Data on file, 2016. Assertio Therapeutics, Inc.