Horizant® takes the bite out of nerve pain from PHN that remains after shingles

In a clinical study of people with Postherpetic Neuralgia (PHN), Horizant® delivered a clinical benefit in PHN pain scores (a ≥30-point improvement from baseline in more than half the patients)13

Review the data
An stethoscope wrapped around an apple

Horizant® 600 mg BID significantly reduced PHN pain as early as Week 112*

  • Reduction in pain score was 2x greater than placebo at Week 1 with Horizant® 600 mg BID12

*Secondary endpoint: This was a secondary endpoint of the study.13 These results should be interpreted within the context of the study design, which was not powered to detect a difference in this endpoint. Therefore, the ability to interpret the P value as significant is reduced.

Reduction of 24-hour average pain score during Week 1 up-titration vs placebo12

Reduction in PHN intensity (10-point scale) from baseline

Reduction in PHN intensity (10-point scale) from baseline for Horizant® vs placebo (P=0.011)12*:

  • Horizant® 600 mg BID (n=107): –0.87
  • Placebo (n=95): –0.43

*Secondary endpoint: This was a secondary endpoint of the study.13 These results should be interpreted within the context of the study design, which was not powered to detect a difference in this endpoint. Therefore, the ability to interpret the P value as significant is reduced.

Patients on Horizant® reported significant improvement in 24-hour PHN nerve pain intensity over 13 weeks13

Reduction in 24-hour average pain intensity score by week13*,†

49% greater reduction in average pain intensity score for Horizant® vs placebo at Week 13

*Calculation 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%.13

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

  • At Week 13, Horizant® 600 mg BID delivered a 49% reduction in mean 24-hour average pain intensity score vs placebo (–2.47 points vs –1.66 points for placebo; P=0.013)13

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.1,13

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.1,13

Horizant® significantly improved pain intensity score over the course of 14 weeks1,13

Horizant® 600 mg BID is the approved dose for PHN, and doses >600 mg BID increased side effects without additional therapeutic benefit1

54% of Horizant® patients had a ≥30% reduction in pain intensity from baseline

Improvement in pain intensity score from baseline to end of maintenance treatment1

Reduction in pain intensity from baseline for Horizant® vs placebo

Improvement in pain intensity score from baseline to end of maintenance treatment1:

 

  • Horizant® 600 mg BID (n=107)*:

– Percent patients who experienced:

>0% improvement in pain intensity score from baseline: 89%

≥10% improvement in pain intensity score from baseline: 78%

≥20% improvement in pain intensity score from baseline: 67%

≥30% improvement in pain intensity score from baseline: 54%

≥40% improvement in pain intensity score from baseline: 47%

≥50% improvement in pain intensity score from baseline: 42%

≥60% improvement in pain intensity score from baseline: 32%

≥70% improvement in pain intensity score from baseline: 24%

≥80% improvement in pain intensity score from baseline: 16%

≥90% improvement in pain intensity score from baseline: 8%

≥100% improvement in pain intensity score from baseline: 6%

*Horizant® 600 mg BID is the approved dose for PHN, and doses >600 mg BID increased side effects without additional therapeutic benefit.1

  • Horizant® 1200 mg BID (n=82):

– Percent patients who experienced:

>0% improvement in pain intensity score from baseline: 88%

≥10% improvement in pain intensity score from baseline: 75%

≥20% improvement in pain intensity score from baseline: 68%

≥30% improvement in pain intensity score from baseline: 59%

≥40% improvement in pain intensity score from baseline: 48%

≥50% improvement in pain intensity score from baseline: 35%

≥60% improvement in pain intensity score from baseline: 30%

≥70% improvement in pain intensity score from baseline: 22%

≥80% improvement in pain intensity score from baseline: 15%

≥90% improvement in pain intensity score from baseline: 11%

≥100% improvement in pain intensity score from baseline: 4%

 

  • Horizant® 1800 mg BID (n=87):

– Percent patients who experienced:

>0% improvement in pain intensity score from baseline: 97%

≥10% improvement in pain intensity score from baseline: 80%

≥20% improvement in pain intensity score from baseline: 75%

≥30% improvement in pain intensity score from baseline: 60%

≥40% improvement in pain intensity score from baseline: 53%

≥50% improvement in pain intensity score from baseline: 43%

≥60% improvement in pain intensity score from baseline: 36%

≥70% improvement in pain intensity score from baseline: 28%

≥80% improvement in pain intensity score from baseline: 22%

≥90% improvement in pain intensity score from baseline: 14%

≥100% improvement in pain intensity score from baseline: 8%

 

  • Placebo (n=95):

– Percent patients who experienced:

>0% improvement in pain intensity score from baseline: 83%

≥10% improvement in pain intensity score from baseline: 65%

≥20% improvement in pain intensity score from baseline: 53%

≥30% improvement in pain intensity score from baseline: 42%

≥40% improvement in pain intensity score from baseline: 34%

≥50% improvement in pain intensity score from baseline: 23%

≥60% improvement in pain intensity score from baseline: 16%

≥70% improvement in pain intensity score from baseline: 9%

≥80% improvement in pain intensity score from baseline: 8%

≥90% improvement in pain intensity score from baseline: 3%

≥100% improvement in pain intensity score from baseline: 1%

*Horizant® 600 mg BID is the approved dose for PHN, and doses >600 mg BID increased side effects without additional therapeutic benefit.1

Patients with PHN discontinued placebo at higher rates than Horizant®1*

6% vs 13% discontinuation rate in the PHN trial (Horizant® vs placebo, respectively)
  • 6% of patients taking Horizant® 1200 mg (n=107) discontinued due to adverse reactions vs 13% for placebo (n=95)1

*From the Horizant® 600 mg BID study arm of the PHN pivotal trial (n=107). Horizant® 600 mg BID is the approved dose for PHN, and doses >600 mg BID increased side effects without additional therapeutic benefit.1

Horizant® was well tolerated in the PHN pivotal trial1

*Treatment-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.1

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

‡In patients treated with Horizant® 600 mg twice daily who reported dizziness (17%), symptoms persisted during treatment in about 6%.1

§In 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.1

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

Horizant® adverse reactions in the PHN pivotal trial
Adverse Reactions Placebo (n=95)

%

 Horizant® 600 mg BID (n=107)

%

 Horizant 1200 mg BID*

%

 Horizant® 1800 mg BID† (n=87)

%
Dizziness‡ 15 17 26 30
Somnolence§ 8 10 11 14
Headache 9 10 10 7
Nausea 5 8 4 9
Fatigue/Asthenia 1 6 4 10
Peripheral edema 0 6 7 6
Insomnia 2 3 5 7
Weight increased 1 3 5 5
Blurred Vision 0 2 5 2

 

*Treatment-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.1

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

‡In patients treated with Horizant® 600 mg twice daily who reported dizziness (17%), symptoms persisted during treatment in about 6%.1

§In 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.1

Next: Prescribing Horizant®

BID=twice daily.