title: MethyPatch Noven.
abstract: Noven Pharmaceuticals is developing a transdermal patch formulation of methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD) [325808]. Phase III trials were completed in February 2002 [438893]; at this time, the company predicted a 2003 launch for the product [441478]. In April 2002, based on pivotal phase III trial results, Noven expected to file an NDA with the FDA in mid-2002 and to launch the product in the second half of 2003 [445181]. In June 2002, the NDA was filed [456552]. The original phase III trials were completed in the first quarter of 2001 [407254]. However, preliminary analysis of the phase III trial, reported in April 2001, suggested that a supplemental study would be required to support the filing [403771]. At this time, an NDA filing, originally planned for the second quarter of 2001, was rescheduled for the first half of 2002 [400122], [407640], [410285], [441478]. As of August 2001, the supplemental study was expected to begin in autumn of that year [417877]. In October 2001, enrolment was initiated in Noven's pivotal, double-blind, placebo-controlled, multicenter phase III study of MethyPatch [427321], and it was completed in February 2002 [438893]. In May 2001, the company was issued patent US-06210705 relating to the transdermal delivery of methylphenidate for the treatment of ADHD [410285]. In June 2001, ABN AMRO predicted sales of US $61 million in 2002, rising to US $74 million in 2005 [422762]. Analysts at Morgan Stanley predicted in May 2002 that the product would make US sales of US $9.1 million in 2003, rising to US $22.5 million in 2006 [454573].
authors.affiliation: University of California at Los Angeles, 90095, USA.
authors.forename: Natasha
authors.initials: N
authors.lastname: Sane
authors.forename: James J
authors.initials: JJ
authors.lastname: McGough
mesh_terms: D000279:Administration, Cutaneous; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects / Q000138:chemical synthesis / Q000378:metabolism / Q000494:pharmacology / Q000627:therapeutic use*; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008774:Methylphenidate / Q000008:administration & dosage* / Q000009:adverse effects / Q000138:chemical synthesis / Q000378:metabolism / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate