US approval for Shire’s Vyvanse
pharmafile | February 28, 2007 | News story | Sales and Marketing |
Shire and New River Pharmaceuticals have been given the green light by the FDA to market anti-ADHD drug Vyvanse.
Shire, which has just announced it is to acquire New River for $2.6 billion, hopes it will strengthen its position in the attention deficit hyperactivity disorder market, where it already has brands such as Adderall XR. The company says Vyvanse is unlikely to be filed in the UK and Europe before 2009.
Vyvanse (lisdexamfetamine) is a stimulant that appears inactive until metabolised in the gastro-intestinal tract. New River developed it to provide lower potential for abuse – one of the key safety fears over ADHD drugs generally. There have been worries over the "buzz" such pills can produce, but in two clinical human drug abuse studies, Shire said Vyvanse produced relatively low "drug-liking effects" responses.
The drug works by linking d-amphetamine to l-lysine, a naturally occurring amino acid. The combination is absorbed and converted to d-amphetamine, and it is this which is responsible for Vyvanse's activity.
US studies show Vyvanse significantly reduces ADHD symptoms throughout the day and has a predictable tolerability profile. Shire says it is this "smoothness" and duration of action across the day, which sets it apart from other drugs on the market.
To be launched in the second quarter of 2007, Vyvanse will be the top promotional priority in Shire's ADHD portfolio. Chief executive Matthew Emmens said Vyvanse was evidence of the group's "commitment to continue to address unmet medical needs and advance the science of ADHD treatment".
Vyvanse includes methylphenidate – the gold standard ADHD treatment, which is also the active ingredient in brands such as Novartis' Ritalin, Celltech's Equasym and Jannsen-Cilag's Concerta XL.
Non-stimulant treatments for ADHD, generally considered to be less effective than stimulants, include Lilly's Strattera (atomoxetine HCI), part of the selective noradrenaline reuptake inhibitor (NRI) class. It provides 24-hour relief from ADHD, unlike most treatments which leave parents and carers coping with an untreated child in the early morning and evening.
NICE estimates 500,000 children suffer from ADHD in the UK.
