J&J has earned a complete response letter and an uncertain delay for its pain drug tapentadol, an extended-release tablet that is one of the company's top experimental products slated for a near-term commercial launch. Significantly, though, J&J says that regulators are not asking for a new trial as they seek additional information on the therapy.
The agency is asking to look at 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," J&J said in a release. "We will engage FDA in active discussions as quickly as possible so that we can address the requests in the Complete Response letter," said Juergen Haeussler, MD, therapeutic area head, analgesia for J&JPRD. "We remain fully committed to bringing tapentadol ER to patients experiencing chronic pain as quickly as possible."
J&J tapped tapentodol as one of its top market prospects back in 2009. It's one of several drugs the pharma giant needs to launch to help overcome several product recalls in recent times. J&J released positive Phase III data on the pain drug just days ago.
- see J&J's release on the CRL
- check out the Reuters story
- here's the release on the Phase III data