Poor J&J. The company, to their credit, decides to license, develop, and commercialize a novel pain product; an area notorious for difficult product development. J&J did succeed in launching the immediate release formulation of tapentadol in 2008 for acute pain. Now in order to enter the chronic pain market, an extended release formulation was designed and developed.
A simple line-extension? No. Not in the eyes of the FDA:
The agency is, however, requesting data regarding the conversion of the extended release formulation used in the clinical efficacy and safety trials to a different extended release formulation that is designed to increase mechanical resistance to breaking or crushing.
I full appreciate what the FDA is trying to do here. It is proper for the FDA to ensure that novel formulations of opioid pain medications are as safe as possible. I question whether these issues could not have been addressed sooner. Now chronic pain patients find themselves waiting for access to a potentially interesting and effective novel medication to treat chronic pain.