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.”