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Janssen Cilag drug receives approval recognition for painkiller
Janssen Cilag has announced that its new prescription drug for severe pain has received recognition of its approval as part of the Mutual Recognition procedure from several European countries, including Spain, Germany, Norway and Italy.
The approval was for the company’s prolonged-release hydromorphone HCl tablets, Jurnista. Hydromorphone belongs in the opioid class of painkillers and it is a semi-synthetic pharmaceutical product. It works by binding to opioid receptors in the central nervous system and smooth muscle.
Trials for the drug showed that concentrations of Jurnista entered a “relatively flat plateau region” for six to eight hours after the dose and remained at this level for 24 hours after the dose. Janssen Cilag says that this proves its extended release capabilities as concentrations remain constant for these periods of time after a once-daily oral dose.
It reported that the most commonly reported side-effects during the clinical trials were constipation, nausea and vomiting.
Janssen Cilag offers other painkilling drugs, such as Durogesic Dtrans, a drug delivered through the skin by patches. The company has been part of the Johnson and Johnson family since 1963 and has origins dating back to 1936, when Cilag was formed. Its UK base of operations is in Saunderton, near High Wycombe.
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