Intrathecal treatment of severe chronic pain

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Intrathecal treatment of severe chronic pain

http://www.medicalnewstoday.com/medicalnews.php?newsid=16558 19 Nov

2004

Elan Corporation, plc today announced that PRIALT (ziconotide) has

received a positive recommendation from the European Committee for

Medicinal Products for Human Use (CHMP), the human medicines scientific

body of the European Medicines Agency. The CHMP has recommend that

Prialt be indicated for the treatment of severe, chronic pain in

patients who require intrathecal (IT) analgesia. The CHMP's positive

recommendation will now be proposed for final marketing approval by the

European Commission. Final approval customarily follows the CHMP's

recommendation in approximately three months.

Today's recommendation is based in part on the Phase III clinical trial,

Study 301, which evaluated the efficacy and safety of IT Prialt in

patients with severe chronic pain who were inadequately controlled by,

or intolerant to, opioids. Prialt has been awarded orphan drug status in

the European Union; products with orphan drug status are for the

diagnosis, prevention or treatment of life-threatening or very serious

rare diseases or conditions.

" We are encouraged by the Committee's positive recommendation and look

forward to receiving final approval in the near future, " said Lars

Ekman, MD, executive vice president, and president Research and

Development, Elan. " Elan remains committed to making this unique orphan

therapy available to those patients in Europe who are burdened by severe

chronic pain, many of whom are currently without adequate relief. "

Severe chronic pain is defined as pain lasting longer than six months

and commonly occurs after major trauma or failed back surgery, but may

be caused by an initial injury or accident.

About PRIALT

Prialt is in a class of non-opioid analgesics known as N-type calcium

channel blockers (NCCBs). A synthetic analogue of a peptide found in a

marine snail known as Conus magus, Prialt selectively blocks calcium

channels on nerves responsible for transmission of pain signals. Prialt

is administered via a programmable IT infusion pump that delivers the

medication directly into the fluid surrounding the spinal cord.

Prialt is currently under review by the U.S. Food and Drug

Administration and action is expected by the end of the year.

About Elan

Elan is a neuroscience-based biotechnology company that is focused on

discovering, developing, manufacturing, selling and marketing advanced

therapies in neurodegenerative diseases, autoimmune diseases and severe

pain.