Horizant^® was well tolerated in the PHN pivotal trial¹

Most common adverse reactions vs placebo (≥2% of patients on Horizant^®)^1,a

^aTreatment-emergent adverse reactions that occurred in ≥2% of patients with PHN treated with Horizant^® 600 mg twice daily and numerically greater than placebo in a placebo-controlled, 12-week clinical trial.

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

^cIn patients treated with Horizant^® 600 mg twice daily who reported dizziness (17%), symptoms persisted during treatment in about 6%.

^dIn patients treated with Horizant^® 600 mg twice daily who reported somnolence (10%), symptoms persisted during treatment in about 27%. In remaining patients, somnolence resolved within 4 to 5 weeks.

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
Lal R, Ellenbogen A, Gidal B. Interindividual variability in the bioavailability of gabapentin enacarbil extended release in healthy adults: an analysis of data from 6 phase I studies. Ther Drug Monit. 2022;44(3):448-454.
Lee DO, Ziman RB, Perkins AT, et al; XP053 Study Group. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med. 2011;7(3):282-292.

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.

Most common adverse reactions vs placebo (≥2% of patients on Horizant^®)^1,a

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

^cIn patients treated with Horizant^® 600 mg twice daily who reported dizziness (17%), symptoms persisted during treatment in about 6%.

Horizant® was well tolerated in the PHN pivotal trial1

Most common adverse reactions vs placebo (≥2% of patients on Horizant®)1,a

References

Most common adverse reactions vs placebo (≥2% of patients on Horizant®)1,a

Horizant^® was well tolerated in the PHN pivotal trial¹

Most common adverse reactions vs placebo (≥2% of patients on Horizant^®)^1,a

Most common adverse reactions vs placebo (≥2% of patients on Horizant^®)^1,a