With the immediate-release version of the painkiller Nucynta having been way back approved in 2008, the extended-release version of the drug has now been approval by the US Food and Drug Administration (FDA).

In a Friday statement, New Brunswick, N. J., conglomerate Johnson & Johnson (J&J)revealed that an extended-release version of the Nucynta pill has received the FDA approval, and it be taken twice a day by adult patients suffering from moderate-to-severe chronic pain.

However, the approval comes with a Risk Evaluation and Mitigation Strategy (REMS) that educates the users about the potential of abuse, misuse, overdose, and psychological or physical dependence on the extended-release drug.

The FDA’s approval to the extended-release Nucynta (tapentadol) version is largely based on a randomized, double-blind, controlled phase III study, which essentially tested the oral medication as a treatment for patients with low-back pain and diabetic peripheral neuropathy.

According to the information shared by J&J’s Janssen Pharmaceuticals unit, the safety of Nucynta was assessed in 1,100 patients with moderate to severe chronic pain over a period of one year; and the drug was found to be safe as well as effective.

Noting that chronic pain is difficult to manage, and affected people keep looking for additional options, Sunil Panchal - president of National Institute of Pain - said in a press release from Janssen that the FDA’s approval of Nucynta “is welcome news for this community and the people who suffer from this often debilitating condition.”