Naropin(REG) now approved for intrathecal administration in the European Union

Main Category: Pain / Anesthetics
Article Date: 04 Mar 2004 - 0:00 PDT


AstraZeneca announced today that its long-acting local anaesthetic Naropin(reg) (ropivacaine) 5.0 mg/ml was recommended for approval in all EU member states for a new route of administration, intrathecal (spinal) administration. This is an extended clinical use within the indication surgical anaesthesia.

'Naropin(reg) has the potential to become the drug of choice for spinal anaesthesia using various doses for different clinical situations,' commented Kjell Ahlan, Global Medical Director for Anaesthesia.

'It is anticipated that Naropin(reg) for spinal anaesthesia will be welcomed as an effective and safe drug both in patients who receive operations on a day case basis as well as in patients who have to stay hospitalised following major surgery.'

In clinical studies, Naropin(reg) was shown to provide excellent spinal anaesthesia and muscular relaxation for orthopaedic, gynaecological or urological surgery and was well tolerated. A dose interval of 15-25 mg seems adequate to achieve good surgical anaesthesia. Naropin(reg) has a favourable efficacy and safety profile.

Naropin(reg) is currently approved for epidural anaesthesia during surgery and post-operative pain relief, pain relief in childbirth, Caesarean section, local infiltration anaesthesia, for surgery using peripheral nerve block techniques and for continuous peripheral nerve block for post operative pain relief.

The Netherlands acted as the Reference Member State in the Mutual Recognition procedure for European approval and Naropin(reg) has already received approval for this new route of administration in Finland, New Zealand, Switzerland, Sweden, Iceland, Mexico, Argentina and Australia.

Naropin(reg) is the latest addition to the AstraZeneca portfolio of anaesthetics, and its sales increased by 36% in 2003, to $106 million.

AstraZeneca is the global leader of the worldwide anaesthesia market with a total market share of 31%.

Other AstraZeneca anaesthesia products include the IV anaesthetic, Diprivan(reg), the topical anaesthetic cream, EMLA(reg), and the local anaesthetics Xylocaine(reg), Marcaine(reg), Carbocaine(reg), and Citanest(reg). Total sales of the Anaesthesia portfolio in 2003 was $941 million.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services.

It is one of the top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Notes to editor:

Spinal (= intrathecal or subarachnoid) block technique involves the injection of local anaesthetic into the cerebrospinal fluid at the lower part of the backbone, thereby temporarily stopping the nerve impulse transmission and the sensation of pain from a part of the body. For surgery, the 5.0 mg/ml concentration of Naropin(reg) is selected so that muscle function is also anaesthetized, and thereby muscle relaxation is provided. Muscle relaxation is often required by the surgeon, especially during major orthopaedic surgery procedures. When general anaesthesia is used, muscle relaxation is instead achieved by addition of a neuromuscular blocking agent to the general anaesthetic agent.

More information on Naropin(reg) and the techniques of nerve blockades are available on: http://www.anaesthesia-az.com. For illustrations of nerve block techniques select 'Millers Atlas'.

Media Enquiries:
AstraZeneca
Jim Minnick
302-886-5135
Jim.minnick@astrazeneca.com

Shire Health International
Rupert Doggett
44-207-471-1500
Rupert.doggett@shirehealthinternational.com

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