Labopharm has submitted a new drug application (NDA) to the FDA for its version of once-daily painkiller tramadol.
The FDA had previously indicated another positive Phase III study was needed before Labopharm could send in a submission, but this was no longer the case, the company reported.
Tramadol is used to relieve moderate-to-moderately-severe pain. It may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Tramadol is in a class of medications called opiate (narcotic) analgesics.