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References

Horizant^® [prescribing information]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2022.
Cundy KC, Sastry S, Luo W, et al. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol. 2008;48(12):1378-1388.
Gralise [prescribing information]. Morristown, NJ: Almatica Pharma LLC.
Neurontin [prescribing information]. New York, NY: Parke-Davis Division of Pfizer Inc.
American Academy of Sleep Medicine. Treatment of Restless Legs Syndrome and Periodic Limb Movement Disorder. Published January 13, 2024. Accessed December 18, 2024. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://aasm.org/wp-content/uploads/2024/03/Treatment-of-RLS-and-PLMD-CPG.pdf
Food and Drug Administration. Orange Book: approved drug products with therapeutic equivalence evaluations [gabapentin enacarbil]. Accessed July 28, 2022. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
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National Heart, Lung and Blood Institute Biologic Specimen and Data Repository. Restless Legs Syndrome Rating Scale. Accessed July 28, 2022. https://biolincc.nhlbi.nih.gov/media/studies/masm/IRLS.pdf?link_time=2019-07-07_21:09:19.282153
Data on file. Azurity Pharmaceuticals, Inc.
Zhang L, Rainka M, Freeman R, et al. A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of gabapentin enacarbil in subjects with neuropathic pain associated with postherpetic neuralgia (PXN110748). J Pain. 2013;14(6):590-603.

Reduction in 24-hour average pain intensity score by week^11,a,b

^aCalculation based on adjusted mean change in 24-hour average pain intensity from baseline for the 600 mg group (2.47) and placebo group (1.66): 2.47 – 1.66 = 0.81; 0.81/1.66 = 0.4879 = 48.8%.¹¹

^bHorizant^® 600 mg twice daily is the approved dose for PHN, and doses >600 mg twice daily increased side effects without additional benefit.¹

PHN clinical trial design^1,11

The efficacy and tolerability of Horizant^® were evaluated in a randomized, double-blind, placebo-controlled study in adults with PHN. Patients (N=376) were required to have a baseline 24-hour average pain score of ≥4 on an 11-point pain intensity numerical rating scale, ranging from 0 (no pain) to 10 (worst possible pain). Patients were excluded if, over the past year, they had certain psychiatric comorbidities, a history of drug or alcohol abuse, hepatic or renal impairment (creatinine clearance <60 mL/min or hemodialysis), abnormal electrocardiogram, uncontrolled hypertension, or a seizure disorder requiring medication.

The primary endpoint was change from baseline to end of maintenance treatment in mean 24-hour average pain intensity score. Additional endpoints included proportion of patients achieving a percent reduction in pain score from baseline and daytime/nighttime worst pain intensity.

Patients on Horizant®reported significant improvement in 24-hour PHN nerve pain intensity over 13 weeks11

References

Reduction in 24-hour average pain intensity score by week11,a,b

PHN clinical trial design1,11

Patients on Horizant^®reported significant improvement in 24-hour PHN nerve pain intensity over 13 weeks¹¹

Reduction in 24-hour average pain intensity score by week^11,a,b

PHN clinical trial design^1,11