Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN)

Abstract

Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.

Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause

“…Given the relatively small number of discontinuations attributed to AEs during the first week of treatment (2.4% in the placebo arm vs 4.7% in G-GR arm), it would seem that AEs were manageable for most women and that the more rapid 1-week titration used in this study (as opposed to the 2-wk titration used in studies of G-GR in postherpetic neuralgia) 14 was suitable for this population of highly symptomatic women, who are younger and generally healthier. The low propensity for drug interactions is also an important component of the safety profile of gabapentin.…”

“…10,13 The slower release afforded by the gastroretentive formulation seems to enhance tolerability and permits a more rapid titration to an efficacious dose. 14 A phase 2 dose-finding clinical study of G-GR in women with VMS 15 demonstrated that 1,800 mg/day was efficacious and had fewer adverse effects than 2,400 mg/day. Earlier phase 3 placebo-controlled studies comparing 1,200 mg once daily and 1,800 mg dosed asymmetrically twice per day (600 mg AM/ 1,200 mg PM) found that the 1,800-mg dose was more efficacious than the 1,200-mg dose and was well tolerated.…”

Randomized Controlled Trial versus Real-World Study in Postherpetic Neuralgia

“…Integrated data from two RCTs (Phase 3, double-blind, randomized, placebo-controlled studies 81-0045 and 81-0062; clinicaltrials.gov identifiers NCT00335933 and NCT00636636) [16,22] and one realworld study (Phase 4, open-label, single-arm study 81-0067) [23] were compared in this analysis. All studies shared a similar G-GR treatment schedule, which included a 2-week titration period, a stable-dose treatment period (8 weeks for the Phase 3 studies and 6 weeks for the Phase 4 study), and a 1-week dose tapering period.…”

“…Detailed patient selection criteria for individual studies have been previously published [16,22,23]. Briefly, men or women aged ≥18 years were eligible to enter the Phase 3 or 4 studies.…”

“…A novel formulation of gabapentin utilizing gastroretentive technology (gastroretentive gabapentin, G-GR) resulted in more efficient drug absorption, improved bioavailability, and reduced dosing frequency from thrice daily to once daily [20,21]. Efficacy and safety of G-GR in management of PHN has been established in two RCTs, and further examined in a real-world study (the only real-world study for any formulation of gabapentin) [16,22,23]. For other first-line treatment options, one realworld study of pregabalin and one of lidocaine patch 5% in treatment of PHN have been performed [23][24][25].…”