I am not a representative of BIEL nor a lawyer and can only offer my opinion and the facts that I dig up along the way.
You could call KW and ask her but IMO the FDA is not going to be the final word on your NSAIDs question.
IMO each company that Partners with BIEL on a OEM/Licensing basis will decide what they can say in their Product Promotions.
If DJO decides that the Chronic Cervical Osteoarthritis (neck pain) Study gives them the right to claim, 'Better than NSAIDS', they will do so and they have the resources to handle a Lawsuit if Pfizer or Bayer have a different opinion.
IMO what BIEL could state is that an FDA Reviewed Study of 200 patients, suffering from chronic cervical osteoarthritis neck pain, comparing ActiPatch to an NSAID of the Cox-2inhibitor family, showed that the Group treated with ActiPatch had significantly reduced pain and experienced greater pain relief than the NSAID Group. Those are all facts confirmed by the FDA.
FDA Summary Document
The clinical data in this 510(k) includes results from three IRB approved, randomized, controlled studies. Additionally, usability testing was conducted to support the OTC use of the device.
• A randomized, controlled trial on chronic cervical osteoarthritis (neck pain): This was a randomized, active-treatment controlled study to evaluate the safety and effectiveness of the ActiPatch medical device to reduce the pain level of patients diagnosed with cervical osteoarthritis. The active-treatment control was an NSAID of the Cox-2inhibitor family. There were 200 intent-to-treat patients, out of which 197 completed the four-week study. There were 142 women (71%) and 58 (29%) men in the study, with an average age of 45 years. The primary endpoint for efficacy was reduction in pain (VAS score) while at rest and being active, over four weeks, when compared to the beginning of the study. The results indicate that ActiPatch significantly reduced pain (measured by VAS pain) associated with COA in the device treatment group, and that the treatment differences between device-treatment and NSAID-treatment groups was significant (p<0.05).
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