Johnson & Johnson (J&J) Pharmaceutical Research & Development has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for tapentadol extended release (ER) tablets, to treat moderate to severe chronic pain.
The company submitted the NDA for the investigational oral analgesic for the management of chronic pain in patients 18 years of age or older, a persistent and debilitating condition that is thought to affect 100 million Americans.
Tapentadol ER tablets work using a novel investigational, centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine re-uptake, two mechanisms that are thought to be responsible for pain relief with tapentadol.
The NDA is based on a full clinical development programme that included Phase III double-blind, randomised, active-and placebo-controlled studies, which showed efficacy for tapentadol ER compared to placebo as well as long-term safety and tolerability.
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