FDA Approved Drugs » 2012
Medical Areas: Musculoskeletal | Neurology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved April 2012
Treatment Area: Restless Legs Syndrome
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 ApprovalThe 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 OneThis 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 TwoThis 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:
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.
Hening WA, Allen RP, Ondo WG, Walters AS, Winkelman JW, Becker P, Bogan R, Fry JM, Kudrow DB, Lesh KW, Fichtner A, Schollmayer E; SP792 Study Group Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States. Movement Disorders : Official Journal of the Movement Disorder Society 2010 Aug 15;25(11):1675-83
Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Högl B, Trenkwalder C, Tacken I, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP710 Study Group One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Medicine 2008 Dec;9(8):865-73
Trenkwalder C, Benes H, Poewe W, Oertel WH, Garcia-Borreguero D, de Weerd AW, Ferini-Strambi L, Montagna P, Odin P, Stiasny-Kolster K, Högl B, Chaudhuri KR, Partinen M, Schollmayer E, Kohnen R; SP790 Study Group Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurology 2008 Jul;7(7):595-604
Oertel WH, Benes H, Garcia-Borreguero D, Geisler P, Högl B, Saletu B, Trenkwalder C, Sommerville KW, Schollmayer E, Kohnen R, Stiasny-Kolster K; Rotigotine SP 709 Study Group Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Medicine 2008 Mar;9(3):228-39
For additional information regarding Neupro or Restless Legs Syndrome, please visit the Neupro web page.
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