Neupro (Rotigotine Transdermal System)

Company
UCB

Approval Status
Approved April 2012

Treatment for
Restless Legs Syndrome

Possible similar drugs
Neupro

Areas
Musculoskeletal , Neurology & Nervous System

Neupro is a transdermal system that provides continuous delivery of rotigotine, a non-ergoline dopamine agonist, for 24 hours following application to intact skin.

Neupro is specifically approved for the treatment of moderate-to-severe primary restless legs syndrome.

Neupro is supplied as a transdermal formula for topical administration. The recommended initial dose is 1 mg/24 hours. Based upon individual response and tolerability, Neupro dosage may be increased weekly by 1 mg/24 hours if tolerated and if additional therapeutic effect is needed. The highest recommended dose is 3 mg/24 hours. Neupro is applied once a day. The adhesive side of the transdermal system should be applied to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The application site for Neupro should be moved on a daily basis. Neupro should not be applied to the same application site more than once every 14 days.

FDA Approval
The FDA approval of Neupro for Restless Legs Syndrome was based on two fixed-dose, randomized, double-blind, placebo-controlled trials. The co-primary efficacy endpoints were changes on the International RLS Rating Scale (IRLS Scale) and a Clinical Global Impression - Improvement (CGI-I) assessment. The IRLS Scale contains 10 items designed to assess a variety of RLS symptoms. The range of scores is 0 to 40, with 0 being absence of RLS symptoms and 40 the most severe symptoms. The CGI-I is designed to assess clinical progress (global improvement) on a 7-point scale.
Study One
This U.S-based, multicenter, 5-arm, parallel-group, fixed-dose trial enrolled 505 subjects with moderate-to-severe RLS. Subjects received placebo or Neupro (0.5 mg/24 hours, 1 mg/24 hours, 2 mg/24 hours, 3 mg/24 hours). Subjects began treatment at a daily dosage of 0.5 mg/24 hours Neupro and were titrated over a four week period to their assigned daily dose followed by a six month maintenance period and 7 day down titration period. Each of the four Neupro arms resulted in a mean change in the IRLS sum score from baseline to the end of treatment. The difference between the two highest treatment groups (2 mg/24 hours and 3 mg/24 hours) and placebo were statistically significant. Of the Neupro-treated arm, 23% had an IRLS score of 0 compared to 9.1% of the placebo arm at the end of the maintenance period. Onset of treatment benefit was seen with the 1 mg/24 hours dose.
Study Two
This European-based multicenter, 4-arm, parallel-group trial enrolled 458 subjects with moderate-to-severe RLS. The subjects received placebo or Neupro (1 mg/24 hours, 2 mg/24 hours, 3 mg/24 hours). Subjects began treatment at a daily dosage of 1 mg/24 hours Neupro and were titrated over a three week period to their assigned daily dose followed by a six month maintenance period and 7 day down-titration period. Each of the three Neupro dose groups showed a mean change in the IRLS sum score from baseline to the end of treatment. The difference between all three treatment groups and placebo was statistically significant. Of the Neupro-treated arm, 24% had an IRLS score of 0 compared to 12% of the placebo arm at the end of the maintenance period. Onset of treatment benefit was seen with the 1 mg/24 hours dose.

Adverse events associated with the use of Neupro for Restless Legs Syndrome may include, but are not limited to, the following:

  • application site reactions
  • nausea
  • somnolence
  • headache

Neupro is a transdermal system that provides continuous delivery of rotigotine, a non-ergoline dopamine agonist, for 24 hours following application to intact skin.The precise mechanism of action of rotigotine as a treatment for Restless Legs Syndrome is unknown but is thought to be related to its ability to stimulate dopamine receptors.

For additional information regarding Neupro or Restless Legs Syndrome, please visit the Neupro web page.

Neupro (Rotigotine Transdermal System) Drug Information

The Neupro (Rotigotine Transdermal System) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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