At Iroko, we believe it is possible to offer new options for responsible pain management. Medical and regulatory organizations have recommended the use of the lowest effective doses of NSAIDs for the shortest duration of time.
We are using innovative proprietary SoluMatrix Fine Particle Technology™ to develop new drug products based on existing NSAIDs to relieve pain at low doses.
Guidance for Responsible Pain Management
In 2005, the FDA issued a public health advisory recommending the use of NSAIDs at the lowest effective dose for the shortest duration of time, consistent with patient treatment goals. These recommendations are particularly important, as the use of NSAIDs is on the rise. In 2012, there were more than 109 million prescriptions in the United States alone.
Small Particles That Are Advancing Analgesics
Iroko has developed the first low-dose NSAIDs using SoluMatrix Fine Particle Technology™. This technology produces NSAIDs as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and is licensed to Iroko for exclusive use in NSAIDs.
Disclosure of clinical trial results: We are committed to conducting our development program in a manner that is transparent, and compliant with applicable laws and regulations. To demonstrate our commitment, we post bibliographies of completed Iroko-sponsored clinical trials in our Clinical Trial Results bibliography. We also include information regarding where, and when the clinical trial results have been presented, as applicable. We post this information regardless of the outcome of the clinical trial.
When results will be posted: We will endeavor to post this information in our bibliography within 12 months of the respective trial’s completion date, and update the bibliography on a quarterly basis. In some instances however, there may be a delay in posting the information if there are reasons to exclude information pertaining to certain trials from the bibliography for example, where there is an agreement with a third party which prevents Iroko from disclosing information about the trial, to allow filing of patent applications, or to comply with publication requirements of certain medical journals.
Note that clinical trial results may be published elsewhere (e.g. in medical journals), before they are available on the Iroko website.
The information is intended to be non-promotional. It may contain information on products and/or indications which have not been approved. Under no circumstances should the information be used for prescribing purposes, or to draw any conclusions about healthcare products, treatments or treatment options.
Iroko Clinical Trials: You can also access information regarding Iroko clinical trials at www.clinicaltrials.gov.
Questions: Questions concerning the information posted on our clinical trial results bibliography may be directed to email@example.com.
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