Johnson and Johnson submits application for tapentadol

A new drug application has been made to the US Food and Drug Administration by Johnson & Johnson for approval of tapentadol hydrochloride immediate release (IR) tablets.

Some 1,800 patients have been treated with the drug – which relieves moderate to severe pain – during clinical trials so far.

A total of two phase three studies have explored the safety and efficiency of multiple doses of tapentadol, particularly among patients suffering from end-stage joint diseases in the hip or knee and those recovering from standard foot surgery.

In addition, several trials have been carried out to test the effect of multiple doses of tapentadol as a treatment for lower back pain and osteoarthritis.

As identified by the clinical trials, side effects of the drug can include nausea, dizziness, vomiting, headache and drowsiness.

Johnson & Johnson has more than 250 operations in 57 countries. The firm has been established in Europe for over 70 years.