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New River to seek approval for new drug
by Robert Burke
for Virginia Business
July 2005
Radford-based New River Pharmaceuti-cals
Inc. says it has taken a key step toward putting a new
drug for treating attention-deficit hyperactivity disorder
on the market.
A clinical trial of 285 patients
ages six to 12 years old showed that New River’s
drug candidate, dubbed NRP104, performed effectively
and had no ill effects, according the company. New River
expects to file a new drug application with the Federal
Drug Administration later this year and hopes to win
approval next year, says the company’s COO and
CFO Krish Krishnan.
New River’s partner in commercialization
of the new drug is Shire Pharmaceuticals Group PLC,
which is based in Great Britain. Krishnan says if the
FDA approves the drug, Shire will offer it as an alternative
to its Adderall XR pill for ADHD. New River’s
product differs from other ADHD products because “it
has… abuse-resistant properties,” Krishnan
says. Though it is a stimulant, “the drug seems
to work only when taken as directed,” he says.
Right now the company has about 31
employees; Krishnan says increasing its work force in
Virginia is a long-term possibility. “The way
we’re thinking about it now is, in the interest
of our shareholders let’s push the first [drug]
through approval,” he says. “Then the company’s
on solid ground, and we can think about expanding.”
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