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New Prescription Pain Treatment Completes European Mutual Recognition Procedure |
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15 May 2006 |
MOUNTAIN VIEW, CA, USA | May 15, 2006 | JURNISTA(TM) prolonged-release tablets (Hydromorphone HCl), a new prescription treatment for severe pain, has successfully completed the Mutual Recognition Procedure in Austria, Czech Republic, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Norway, Portugal, Slovak Republic, Slovenia and Spain. The countries mutually agreed to recognize the approval of JURNISTA granted by the Reference Member State, Denmark.
JURNISTA was developed by ALZA Corporation and utilizes the OROS® Push-Pull delivery system to release the opioid hydromorphone at a consistent rate. It will be registered and marketed by Janssen-Cilag companies in Europe. ALZA and Janssen-Cilag are affiliates of Johnson & Johnson.
As with all opioid analgesics, hydromorphone exerts its pharmacological effects by binding to specific opioid receptors predominantly located in the central nervous system. Following oral dosing of JURNISTA, data show that hydromorphone hydrochloride is released continuously for 24 hours. The continuous release of hydromorphone results in relatively consistent plasma concentrations for approximately 24 hours post-dose. JURNISTA will be available in four dosage strengths - 8 mg, 16 mg, 32 mg and 64 mg prolonged-released tablets.
In clinical trials with JURNISTA, the most commonly reported adverse reactions were constipation, nausea, and vomiting. These symptoms are common with opioid analgesics and can usually be managed by laxatives, antiemetics, or dose reduction, as needed.
ALZA Corporation is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable, and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA's drug delivery technologies.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson 's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson 's Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov or on request from the Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.)
SOURCE: ALZA Corporation |
