Home > Press > Iroko Pharmaceuticals Reports Encouraging Results from Study of Naproxen Formulated Using a Proprietary, Patented, Nanotechnology Platform
Abstract:
First Data Reported From Iroko Research Program To Build Portfolio of Lower-Dose NSAIDs
Iroko Pharmaceuticals Reports Encouraging Results from Study of Naproxen Formulated Using a Proprietary, Patented, Nanotechnology Platform
Philadelphia, PA | Posted on January 6th, 2011
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.
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.1 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 (Tmax) 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 (Cmax) 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.
About Naproxen: Naproxen is one of the most widely used NSAIDs. In 2010, nearly 17 million prescriptions for naproxen products were written in the US alone.2
1 Source: Public Health Advisory - FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDS). July 7, 2005.
2 Source: SDI
NAPROSYN® is a registered trademark of Syntex Pharmaceuticals International Limited
####
About Iroko Pharmaceuticals
Iroko is a pharmaceutical company committed to the development and commercialization of currently marketed pharmaceutical products in specialty therapeutic areas. Iroko is focused on the maximization of the revenue potential of currently marketed products through directed selling and marketing efforts and product-life-cycle management activities including development of new formulations to improve patient therapies. Iroko currently has three products under development, using iCeutica's proprietary SoluMatrix™ Platform nanotechnology. Iroko is headquartered in Philadelphia, PA.
For more information, please click here
Contacts:
Phoenix IP Ventures
Lisa Gray, Managing Partner
267-765-3233
Copyright © Iroko Pharmaceuticals
If you have a comment, please
Contact us.
Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
Bookmark:
News and information
Beautiful "flowers" self-assemble in a beaker: Elaborate nanostructures blossom from a chemical reaction perfected at Harvard May 17th, 2013
Artificial Forest for Solar Water-Splitting: Berkeley Lab Researchers Report First Fully Integrated Artificial Photosynthesis Nanosystem May 17th, 2013
Moth-Inspired Nanostructures Take the Color Out of Thin Films May 17th, 2013
NIA Public Briefing: Nanotechnology and the Council of Europe May 17th, 2013
Possible Futures
Lifeboat publishes its first book: The Lifeboat Foundation has published its first book, "The Human Race to the Future: What Could Happen -- and What to Do" May 14th, 2013
UC Santa Barbara History Professor's Book Elucidates, Celebrates ‘Visioneers' May 14th, 2013
Conceptual Nanomedical Lipofuscin Removal Strategy April 29th, 2013
The Global Desalination Market 2013-2023 April 24th, 2013
Nanomedicine
Nanotechnology could help fight diabetes: Injectable nanogel can monitor blood-sugar levels and secrete insulin when needed May 16th, 2013
Nanobiotix Revenue for the 1st quarter of 2013 May 15th, 2013
Pitt Chemists Demonstrate Nanoscale Alloys So Bright They Could Have Potential Medical Applications: “Think about a particle that will not only help researchers detect cancer sooner but be used to treat the tumor, too.” May 15th, 2013
Using clay to grow bone: Researchers use synthetic silicate to stimulate stem cells into bone cells May 15th, 2013
Announcements
Artificial Forest for Solar Water-Splitting: Berkeley Lab Researchers Report First Fully Integrated Artificial Photosynthesis Nanosystem May 17th, 2013
Moth-Inspired Nanostructures Take the Color Out of Thin Films May 17th, 2013
NIA Public Briefing: Nanotechnology and the Council of Europe May 17th, 2013
Scientists capture first direct proof of Hofstadter butterfly effect May 17th, 2013