on Thursday stepped up its effort to become the one-stop shopping source for treating attention deficit hyperactivity disorder.
The British drugmaker asked the
Food and Drug Administration
to approve Connexyn, an extended-release version of an old blood-pressure treatment, for treating ADHD in children ages 6 to 17. The once-daily drug is one of three experimental ADHD drugs from Shire and/or its partners before the FDA.
Shire sells the market-leading ADHD drug in the U.S., extended-release Adderall XR, as well as an older version of Adderall. The immediate-release Adderall is a minor product due to generic competition, and Shire recently
agreed to sell that version of the drug to
recently began selling Daytrana, an ADHD drug delivered via a skin patch.
The active ingredient in Shire's Connexyn is guanfacine, the same ingredient in a blood pressure medication that has been available in the U.S. for 20 years and which has long been a generic product. Guanfacine has been used "off-label" to treat ADHD. Although the FDA hasn't approved the drug for ADHD, doctors are permitted to prescribe a drug for any use once the agency has approved it for a single disease or condition.
Shire says its drug is different from generic guanfacine because Connexyn is an extended-release formulation, whereas generic guanfacine is an immediate-release drug.
A Strategic Move
If the FDA approves Connexyn, Shire would gain a marketing tactic, because the experimental drug isn't a stimulant.
Right now, there's only one FDA-approved drug for ADHD that isn't a stimulant -- Strattera from
. However, Strattera carries a "black box" warning -- the FDA's strongest alert -- about suicidal thoughts among children and adolescents and a warning about possible liver damage.
Another nonstimulant, Sparlon, from
, was recently
rejected by the FDA.
Delivering a nonstimulant ADHD drug has added importance, because the FDA recently told several drugmakers to toughen their drug labels to warn patients and doctors about cardiovascular risks and potential psychiatric problems.
The skin-patch drug Daytrana contains methylphenidate, a stimulant found in
Ritalin LA, generic Ritalin and
Johnson & Johnson's
Concerta. Drugs containing methylphenidate have warnings about heart damage and psychiatric risks.
The amphetamine-based Adderall and Adderall XR already carry a black box warning about the risks of amphetamine abuse leading to heart damage and sudden death.
Next year, Shire expects to hear from the FDA on its application for SPD465, which contains the active ingredient in Adderall XR. But SPD465 is being targeted for adults and is effective for 16 hours. Adderall XR works for 12 hours, and it is approved for children aged 6 and over, as well as for teenagers and adults.
But the main event for Shire will take place in early October, when the FDA is expected to rule on NRP-104, which was developed by
New River Pharmaceuticals
. Shire has a marketing deal with New River for this amphetamine derivative, which the companies say has fewer side effects and abuse potential than standard amphetamine-based drugs.