Iroko reports positive results from Phase I clinical study of nanotechnology based unique formulation of naproxen

Iroko Pharmaceuticals, LLC today reported the results of the Phase I clinical study of its unique formulation of naproxen, a widely used pain medication, using proprietary, patent protected nanotechnology.

“Through our nanotechnology based formulation efforts we intend to become a leader in addressing the clear need for more efficient and effective options for the treatment of pain relief”

The data, which showed that the investigational formulation attained peak concentration in the body faster than a currently marketed immediate-release formulation, are the first to be publicly reported by Iroko since the company initiated its nanotechnology based development program.

"Through our nanotechnology based formulation efforts we intend to become a leader in addressing the clear need for more efficient and effective options for the treatment of pain relief," said John Vavricka, Iroko's Chief Executive Officer. "In addition, we are applying nanotechnology not only to naproxen but also to other NSAIDs (non-steroidal anti-inflammatory drugs), one of the largest classes of pain-relieving medicines."

Vavricka continued, "Our objective is to deliver NSAIDs that are effective at lower and more tolerable doses, as is consistent with the directive from the US Food and Drug Administration that NSAIDs should be used at the lowest effective dose for the shortest possible duration. We believe that this platform will enable the development of NSAID products at significantly lower doses without compromising the onset of action and effectiveness of such products. We are also exploring other potential benefits of the nanotechnology formulations resulting from their fast dissolution."

"These Phase I results further validate our technology and strengthen our commitment to nanotechnology formulations as a strategic initiative for our company. We look forward to continuing our research and development utilizing this Platform."

Iroko's investigational NSAID products are manufactured with the proprietary, patented, SoluMatrix^™ nanoformulation technology of Iroko partner, iCeutica Inc. The technology enables production of sub-micron, fast-dissolving, readily scalable drug particles.

The data reported today resulted from a single-dose, crossover, pharmacokinetics study that enrolled 40 healthy subjects. The study compared Iroko-formulated naproxen in a 400 mg dose that was only 80 percent of the oral dose of Naprosyn® 500 mg, a currently marketed, immediate-release brand of naproxen.

Despite the lower dosing of the nanotechnology formulated naproxen, the mean time to peak concentration in the blood (T_max) for the Iroko formulation was significantly faster than for Naprosyn®: specifically, 60% faster (1.9 hours versus 4.8 hours) when study subjects had fasted prior to drug administration, and 76% faster (4.3 hours versus 17.7 hours) when they had eaten prior to drug administration.

Under both fed and fasting conditions, the subject-to-subject variability in the time to maximum concentration was considerably lower for the nanotechnology formulation than for Naprosyn®.

The study also compared the 400-mg dose of Iroko-formulated naproxen to a 200-mg dose under fasting conditions. The two doses exhibited dose-proportional changes in both peak concentration (C_max) and exposure (AUC).

Iroko is progressing nanotechnology formulations of two other NSAIDS. Phase I pharmacokinetic and Phase II proof-of concept studies of each of these investigational formulations have been completed. The company plans to report the data for these studies at a later date.