Presented at the 2013 AAPM Annual Meeting « Back

Safety And Efficacy Of Gastroretentive Gabapentin In Real-World Clinical Practice For Treatment Of Patients with Postherpetic Neuralgia (PHN)

Edward M. Tavel, MD, etavel@painchas.com¹, Amanda B. McFann, MSN NP-C², Michael Sweeney, MD³, (1) Pain Specialists of Charleston, P.A., Charleston, South Carolina, (2) Pain Specialists of Charleston, North Charleston, South Carolina, (3) Depomed Inc, Menlo Park, California

Introduction: We evaluate the safety and effectiveness of once-daily gastroretentive gabapentin (G-GR) for treatment of PHN in real-world clinical practice. Methods: Open-label, multicenter study in patients with PHN aged ≥18 years. Eligible patients titrated to a dosage 1800 mg G-GR over 2 weeks, for total treatment of 8 weeks. Efficacy was assessed using a visual analog scale (VAS) and the Brief Pain Inventory (BPI). Patient Global Impression of Change (PGIC) scale was completed at Week 8. Treatment-emergent adverse events (TEAEs) were assessed. The protocol was IRB approved and all patients provided informed consent. To reflect clinical practice, no exclusion criteria beyond those in the product label were added. Results: The mean percent change in VAS score from Baseline was -26.5%/-30.6% (Week 2/Week 8). The proportion of responders in VAS (≥30% reduction from Baseline) was 45.8%/53.2% (Week 2/Week 8). Patients with ≥50% reduction in VAS score from Baseline was 40.5%/33.2% (Week 2/Week 8). BPI were all significantly reduced by Week 8. At Week 8 for the PGIC 51.1% of patients were considered "Very much" or "Much" improved compared with symptoms at study entry. G-QD was generally well tolerated. A total of 37 (18.8%) patients experienced TEAEs that led to study discontinuation. No patient died and 5 (2.5%) patients experienced serious TEAEs; none was deemed by investigators to be related to treatment with G-GR. The most common G-GR-related TEAEs were dizziness (12.2%) and somnolence (5.8%). Conclusions: In real-world clinical practice, G-GR appears an effective, well-tolerated treatment option for PHN.

Funding: Study funded by Depomed Inc.