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. NRP290 is a novel opioid and is a conditionally bioreversible derivative of hydrocodone.
The preclinical data indicates that NRP290 has the potential 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.
“Our research indicates that the US prescription drug market for various acute pain conditions is in excess of five billion doses annually,” said Krish Krishnan, New River’s chief operating and financial officer. “In addition, we believe that this drug category could be considered to be underutilized medically because of concerns relating to potential drug abuse of the opioids that represent the ‘gold standard’ for efficacy in this drug class.”
The US Drug Enforcement Agency (DEA) reports that just as sales and production of hydrocodone products have increased significantly in recent years, so has illicit use. The abuse of hydrocodone, according to the DEA, occurs predominantly by oral administration.