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].