This portion of the website is intended for Healthcare Professionals.

For moderate to severe primary RLS

HORIZANT: An effective treatment option for your RLS patients1,2

HORIZANT is the only gabapentinoid FDA approved to treat RLS

HORIZANT relieves a range of symptoms in your adult patients with moderate to severe primary RLS.1,2

The International RLS Rating Scale (IRLS) measures the range of symptoms that RLS patients experience.

HORIZANT significantly reduced mean International RLS Rating Scale total score in a 12-week pivotal trial.2

Horizant significantly reduced mean IRLS Rating Scale total score in a 12-week pivotal trial

RLS symptom reduction as soon as Week 1

HORIZANT significantly reduced mean IRLS scores at Week 1

42% reduction from baseline at Week 1 (vs 25% for placebo; P<0.0001)

Horizant showed 42 percent reduction from baseline at Week 1 vs 25 percent for placebo
Study DesignThe efficacy and tolerability of HORIZANT was demonstrated in a 12-week randomized, double-blind, placebo-controlled study in adults with moderate to severe primary RLS. Patients received HORIZANT 600 mg (n=114), 1200mg (n=111), or placebo (n=96) once daily. Eligible subjects had RLS symptoms for ≥15 nights 1 month prior to screening, RLS symptoms for ≥4 of the 7 consecutive nights during baseline, an IRLS total score of ≥15 at beginning and end of baseline, and had discontinued RLS treatments for ≥2 weeks prior to baseline. Subjects with a history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment were excluded.1,2Primary EndpointsThe coprimary outcomes were mean change from baseline in IRLS total score and proportion of responders on the investigator-rated Clinical Global Impression of Improvement (CGI-I) scale at Week 12.1

Continued RLS symptom relief at Week 12

HORIZANT 600 mg significantly reduced mean IRLS scores at Week 122

In clinical trials of HORIZANT, the most common adverse reactions (≥5% and at least 2 times the rate of placebo) in patients with RLS were somnolence/sedation and dizziness.1

The recommended dosage of HORIZANT for RLS is 600 mg taken once daily with food at about 5 PM. A daily dose of 1200 mg provided no additional benefit compared with the 600-mg dose and caused an increase in adverse reactions.1

40.8% reduction vs placebo2

IRLS Rating Scale: Total score by visit1,2

IRLS Rating Scale total score by visit Horizant vs placebo

Symptom assessment for RLS patients

The IRLS Rating Scale evaluates the range and severity of RLS symptoms3

Ten factors measured3:

  • RLS discomfort in arms or legs
  • Urge to move
  • Movement brings relief
  • Sleep disturbances
  • Severity of RLS sleepiness
  • Overall severity of RLS
  • Frequency of symptoms
  • Severity on an average day
  • Impact on daily activities
  • Mood disturbance

Patients answer 10 questions in which they rate the severity of RLS symptoms

The IRLS Rating Scale is used to assess the severity of a patient’s RLS symptoms. Patients answer 10 questions in which they rate their symptoms from 0 to 4, with 0 being the absence of symptoms and 4 being very severe. Patients' total scores range from 0 to 40. The IRLS Rating Scale was validated in a controlled study and found to have high levels of internal consistency, interexaminer reliability, and test-retest reliability.3

mild moderate, severe, very severe RLS rating scales

Sustained RLS symptom improvement from baseline

HORIZANT had a significantly greater percentage vs placebo of CGI-I responders as early as Week 1 and sustained through Week 122

Responders on the CGI-I scale were defined as having a rating of “much improved” or “very much improved” at Week 12, last observation carried forward.4

The CGI-I is a 7-point scale that allows the investigator to rate the patient’s overall change in RLS symptoms since baseline, whether or not, in the opinion of the investigator, the change is related to study drug treatment.4

Questions about the efficacy data?

Request a Rep Visit

Percent responders on CGI-I scale2

Graph depicting patient improvement on Horizant over 12 weeks
once-daily dose icon

Once-daily dosing

Learn More
beaker icon

Pharmacologic technology

Learn About PROdrug Technology

VIEW INDICATION AND FULL IMPORTANT SAFETY INFORMATION

  • Effects on DrivingHORIZANT may cause significant driving impairment. The duration of driving impairment after starting therapy is unknown. Patients should not drive until they have enough experience on HORIZANT to know if it impairs their driving. Patients’ ability to assess their driving competence and degree of somnolence caused by HORIZANT can be imperfect.
  • Somnolence/Sedation and DizzinessHORIZANT causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have enough experience on HORIZANT to know if it impairs their ability to perform these tasks.

Important Safety Information for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS:

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night.

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Effects on Driving

HORIZANT may cause significant driving impairment. The duration of driving impairment after starting therapy is unknown. Patients should not drive until they have enough experience on HORIZANT to know if it impairs their driving. Patients’ ability to assess their driving competence and degree of somnolence caused by HORIZANT can be imperfect.

Somnolence/Sedation and Dizziness

HORIZANT causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have enough experience on HORIZANT to know if it impairs their ability to perform these tasks.

Lack of Interchangeability With Gabapentin

HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The same dose of HORIZANT results in different plasma concentrations of gabapentin relative to other gabapentin products. The safety and effectiveness of HORIZANT in patients with epilepsy have not been studied.

Suicidal Behavior and Ideation

HORIZANT is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. As a prodrug of gabapentin, HORIZANT also increases this risk. 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. Anyone considering prescribing HORIZANT must balance the risk of suicidal thoughts or behavior with the risk of untreated illness.

Patients, caregivers, and families should be informed that HORIZANT increases the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. HORIZANT is a prodrug of gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved.

It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. HORIZANT should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Discontinuation of HORIZANT

When discontinuing HORIZANT, patients with RLS receiving 600 mg or less once daily can discontinue the drug without tapering. If the recommended dose is exceeded, the dose should be reduced to 600 mg daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.

In patients with PHN receiving HORIZANT twice daily, the dose should be reduced to once daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.

Tumorigenic Potential

In an oral carcinogenicity study, gabapentin enacarbil increased the incidence of pancreatic acinar cell adenoma and carcinoma in male and female rats. The clinical significance of this finding is unknown.

ADVERSE REACTIONS

The most common adverse reactions for patients with RLS (incidence >10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness.

The most common adverse reactions for patients with PHN (incidence >10% and greater than placebo) were dizziness, somnolence, and headache.

DRUG INTERACTIONS

Gabapentin enacarbil is released faster from HORIZANT Extended-Release tablets in the presence of alcohol. Consumption of alcohol is not recommended when taking HORIZANT.

HORIZANT taken in conjunction with morphine causes increased somnolence/sedation, dizziness, and nausea.

USE IN SPECIAL POPULATIONS

Pregnancy and Lactation

Pregnancy Category C. There are no adequate and well-controlled studies with HORIZANT in pregnant women. In nonclinical studies in rat and rabbits, administration of gabapentin enacarbil was developmentally toxic when administered to pregnant animals at doses and gabapentin exposures greater than those used clinically. HORIZANT should be used during pregnancy only if potential benefit justifies potential risk to fetus.

It is not known whether gabapentin derived from HORIZANT is secreted in human milk; however, gabapentin is secreted into human milk following oral administration of gabapentin products. Because of the potential for adverse reactions in nursing infants from HORIZANT, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of HORIZANT in pediatric patients have not been studied.

Geriatric Use

Clinical trials of HORIZANT for the treatment of RLS did not include a sufficient number of patients 65 years and older to determine whether they respond differently from younger individuals. Because elderly patients are more likely to have a decreased renal function, the frequency of dosing may need to be adjusted based on calculated creatinine clearance in these patients.

Renal Impairment

Gabapentin is known to be almost exclusively excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. The dose of HORIZANT should be adjusted in patients with renal impairment based upon creatinine clearance. HORIZANT is not recommended for treatment of RLS in patients receiving hemodialysis.

For additional safety information, consult the HORIZANT full Prescribing Information here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This site is intended for US residents only.

HORIZANT is a registered trademark of Arbor Pharmaceuticals, LLC.

© 2018 Arbor Pharmaceuticals, LLC. All rights reserved. July 2018. PP-HOR-US-0287