First ADHD skin patch approved in the US
US for Daytrana, a methylphenidate skin patch developed with
Noven's transdermal technology, making it the first non-oral
medication for the treatment of attention deficit hyperactivity
disorder (ADHD) for children aged six to 12, in a market worth
$200m (€165m) in sales per year.
Daytrana has the same active ingredient as Novartis's Ritalin and Alza's Concerta, but is delivered with Noven's DOT Matrix technology through the skin into the bloodstream, providing consistent release throughout the day and more efficient administration.
Shire is already a leader in the ADHD market, holding more than 25 per cent, with its two attention-deficit drugs Adderall and Adderall XR accounting for almost half of the company's $1.6bn revenues last year.
Yet with an estimated 2.5m US children using ADHD drugs, the Basingstoke-based company is battling to fend off challenges from generics and is currently fighting to protect Adderall XR's patent in court against Barr Laboratories and Teva Pharmaceuticals.
As part of Daytrana's licence agreement, Shire paid Noven $25m in 2003 and will pay another $50m now that the Food and Drug Administration (FDA) has approved the drug, with $75m more conditioned upon the achievement of certain sales targets.
"The patch was conceived of and formulated here at Noven in Miami, Florida, and is being manufactured here as well," Noven spokesman Joseph Jones told In-PharmaTechnologist.com.
"Among other challenges [the patch's production faces], Daytrana delivers methylphenidate, a Schedule II controlled substance, so a wide range of security measures are required by the Drug Enforcement Administration (DEA) throughout the manufacturing process."
Schedule II controlled substances are those which have the highest potential for abuse but also have an approved medical use, such as the treatment of pain.
This means the manufacturer is under pressure from the DEA to ensure security in the manufacturing of the patch, from housing the raw materials to storage and shipment.
"The approval of Daytrana is important news for ADHD patients, their families and healthcare providers," said Shire CEO Matthew Emmens.
"In addition to being the only patch treatment for ADHD, it offers a convenient option to deliver medicine for those diagnosed with ADHD."
In clinical trials it was found that wearing a Daytrana patch for 9 hours provided a duration of effect of 12 hours, though some experts have expressed concerns because the drug can enter the blood stream more directly than with a pill.
Shire said it picked Noven because it can make patches of small size, proper adhesion and low irritation.
Its DOT Matrix transdermal technology uses a semi-solid suspension of microscopic concentrated drug cells evenly dispersed through an uncompromised silicone adhesive.
This is achieved by loading acrylic with high concentrations of drug and then adding a silicone adhesive which repels the drug/acrylic blend much like oil in water.
Thus, the high diffusion gradient between each drug cell and the skin causes the drug to penetrate the skin with efficiency.
The adhesive keeps the patch in place through vigorous activities like swimming, while its high capacity means that with less drug in a smaller patch, the same amount of drug is delivered into the system.
Noven's prescription patches are approved in over 30 countries and, apart from Shire, the Miami-based company boasts Novartis, Endo and Procter & Gamble in its clientele.
