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news.New River Pharmaceuticals has filed a new drug application with the FDA for the investigational compound NRP104 being developed in collaboration with Shire Pharmaceuticals for the treatment of attention deficit hyperactivity disorder in children aged six to twelve.
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New River said that the application had been completed on schedule and that it anticipates approval and subsequent launch for the drug in 2006.
In addition, the company has announced results of several hydrolysis studies of NRP104 that demonstrated it would be more difficult to extract amphetamine from NRP104 than from other widely available alternatives.
New River conducted studies examining the extractability of amphetamine from NRP104 using a wide variety of solutions under varying conditions. The results indicate that drug tampering of NRP104 capsules is difficult and complex.
“These results enhance our confidence in the promise of NRP104 as an improved treatment for ADHD because of its reduced abuse potential relative to other ADHD treatments,” said Suma Krishnan, New River’s vice president of product development. “We believe that the complexity involved in extracting amphetamine from the NRP104 capsule and the low yields from the extraction process make NRP104 a less attractive drug for tampering.”