Prialt receives positive CHMP recommendation for intrathecal treatment of severe chronic pain

November 18, 2004

Dublin, Ireland - November 18, 2004 - Elan Corporation, plc today announced that PRIALT(tm) (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.
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. Elan's (NYSE: ELN) shares trade on the New York, London and Dublin Stock Exchanges.

Safe Harbor/Forward Looking Statements
This news release contains forward-looking statements by Elan that involve risks and uncertainties and reflect Elan's judgment as of the date of this release. Actual events or results may differ from Elan's expectations. For example the European Commission and/or the FDA may not grant final marketing approval for PRIALT or may not do so in the time frame or on the terms anticipated by Elan. A further list of risks, uncertainties and other matters can be found in Elan's Annual Report on Form 20-F for the year ended December 31, 2003, as amended, and in Elan's Reports of Foreign Issuer on Form 6-K filed with the Securities and Exchange Commission. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Ketchum UK

Related Chronic Pain Articles from Brightsurf:

Researchers are developing potential treatment for chronic pain
Researchers from the University of Copenhagen have developed a new way to treat chronic pain which has been tested in mice.

Molecular link between chronic pain and depression revealed
Researchers at Hokkaido University have identified the brain mechanism linking chronic pain and depression in rats.

How chikungunya virus may cause chronic joint pain
A new method for permanently marking cells infected with chikungunya virus could reveal how the virus continues to cause joint pain for months to years after the initial infection, according to a study published Aug.

Gastroesophageal reflux associated with chronic pain in temporomandibular joint
Gastroesophageal reflux (GERD) is associated with chronic, painful temporomandibular disorder -- pain in the temporomandibular joint -- and anxiety and poor sleep contribute to this association, according to a study in CMAJ.

One step closer to chronic pain relief
While effective drugs against chronic pain are not just around the corner, researchers from Aarhus University, Denmark, have succeeded in identifying a protein as a future potential target for medicinal drugs.

Gut bacteria associated with chronic pain for first time
In a paper published today in the journal Pain, a Montreal-based research team has shown, for the first time, that there are alterations in the bacteria in the gastrointestinal tracts of people with fibromyalgia.

Nearly 5.4 million cancer survivors suffer chronic pain
A new report finds about one in three cancer survivors (34.6%) reported having chronic pain, representing nearly 5.4 million cancer survivors in the United States.

New opioid speeds up recovery without increasing pain sensitivity or risk of chronic pain
A new type of non-addictive opioid developed by researchers at Tulane University and the Southeast Louisiana Veterans Health Care System accelerates recovery time from pain compared to morphine without increasing pain sensitivity, according to a new study published in the Journal of Neuroinflammation.

New target for chronic pain relief confirmed by scientists
A research group at Hiroshima University observed a potential new target for chronic pain treatment.

Menopause symptoms nearly double the risk of chronic pain
In addition to the other health conditions affected by estrogen, it has also been shown to affect pain sensitivity.

Read More: Chronic Pain News and Chronic Pain Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to