Non-steroidal anti-inflammatory drugs (NSAIDs) that have been ‘nano-formulated’ may allow pain relief at lower, more tolerable doses, according to three Phase II trials reported Nov 7 at the American College of Rheumatology’s annual meeting.
The three trials, directed by Philadelphia-based Iroko Pharmaceuticals, involved more than 650 dental patients with acute pain after dental surgery.* Nano-formulation of the NSAID compounds involves their reduction to smaller-size particles that are able to dissolve more efficiently, Iroko explains.
The nano-formulated prescription drugs used in the three trials (naproxen, diclofenac, and indomethacin) allowed an average 20% reduction in dose without reduced effectiveness vs standard formulation doses – a potential benefit given the need to balance NSAIDs’ pain reduction with the risks of their long-term use, such as ulcers and GI bleeds. And any benefit could be wide-ranging, since some 97 million prescriptions are written annually in the US for these three drugs alone.
Additionally, all three of the nano-formulated drugs worked faster than the corresponding higher dose standard formulation, the researchers report. For example, the mean time to pain relief for nano-formulated naproxen 400 mg was just over 60 minutes, versus more than 90 minutes for standard naproxen 500 mg.
Hoping to confirm the Phase II results reported to the American College of Rheumatology, the company now plans Phase III trials “in anticipation of a 2012 regulatory filing to obtain marketing approval of our first new product.”
For details on the study results, see information on the Iroko website http://www.iroko.com/news.
Source: Iroko Pharmaceuticals, LLC, news releases, Nov 7 and Sep 15, 2011
* “The Phase 2 trials used an acute, dental-pain model that is validated in assessing NSAIDs. All of the trials were multisite, randomized, double-blind, single-dose, parallel-group, placebo-controlled studies; two of the trials also included a second active-treatment comparator group. All the study subjects, 18-50 years old, had at least two third molars extracted and experienced moderate to severe pain within six hours after surgery.”