NEW RIVER FILES NEW DRUG APPLICATION FOR NRP290

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New River Pharmaceuticals has announced that it has submitted an investigational new drug application to the FDA for NRP290, New River's second compound under development. NRP290, a novel opioid, is a conditionally bioreversible derivative of hydrocodone.

Pending clearance by the FDA, New River expects to commence clinical trials later this year to assess the safety and efficacy of NRP290 as a treatment for acute pain.

Preclinical data indicate that when taken orally, the bioavailability of hydrocodone and hydromorphone levels from NRP290 was comparable to hydrocodone bitartrate at therapeutic levels but that there was reduced bioavailability of hydrocodone and hydromorphone at supertherapeutic doses. The significance of this preclinical data is that they indicate the potential for NRP290 to provide pain relief at therapeutic doses without a proportionate increase in pharmacokinetic levels. This property has yet to be demonstrated in human trials. Preclinical data also indicate that the therapeutic components of NRP290 had reduced bioavailability when taken by intranasal and intravenous routes, and demonstrated limited release in various chemical and enzymatic extraction studies.