Table 3 New products in development for treatment of ADHD in children and adolescents: overview of compounds not yet available in England and Germany
Active ingredient | Abbreviation/Pharmaceutical preparation | Trade name (US) | Manufacturer | Approval status (US) | Notes |
|---|---|---|---|---|---|
Methylphenidate hydrochloride | MPH-MR08 (modified-release preparation) | RitalinR LA (using SODAS delivery system developed by Elan) | Novartis | available in US and Switzerland | Â |
Methylphenidate hydrochloride | MPH-TDS Patch for transdermal drug delivery (o.a.d); 12 h duration of action | DaytranaR DOT matrix transdermal technology | Shire (in license from Noven) | US approval (children age 6–12 years) April 2006; 2nd line to oral drugs | Skin sensitization reported in 13–22% of subjects wearing the patch; product had been deemed non-approvable by FDA before (April 2003) |
Dexmethylphenidate, a non-racemic form of methylphenidate: | d-MPH (the active isomer of methylphenidate) | FocalinR | Novartis (in license from Celgene) | Approved in US | Â |
Dexmethylphenidate, a non-racemic form of methylphenidate: | d-MPH-ER (extended release formulation) | FocalinR XR | Novartis (in license from Celgene) | US approval (for "children, adolescents, and adults") May 2005 | Â |
Lisdexamphetamine dimesylate | LisDEX; (pharmaceutical preparation with a o.a.d. dosing schedule) | NRP104 | Shire (in license from New River Pharmaceuticals) | US approval (for children age 6–12 years) granted in 2007 | Reduced abuse potential expected because amphetamine is linked to L-lysine and does no become active until metabolized in the gastrointestinal tract |
Mixed amphetamine salts | MAS (immediate and extended release formulations | AdderallR, AdderallR XR | Shire | Available in US | Unlikely to be approved in Europe |
Modafinil Successor compound: Armodafinil | MOD; dopamine reuptake inhibitor; effects on neuropetides possible ARM | SparlonR (licensed in US and UK as ProvigilR for narcolepsy) NuvigilR | Cephalon (SparlonR was planned to be co-promoted in the US by McNeil, a sister company of Janssen-Cilag) | After receiving a non-approvable letter for modafinil in ADHD from the FDA in August 2006, Cephalon refocused its R&D on armodafinil [61] | Suspected serious adverse events (skin rash/Stevens-Johnson syndrome) in association with modafinil |