Prialt (for pain) receives FDA approval

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Elan Receives FDA Approval for Prialt for Severe Chronic Pain

29 Dec 2004

Elan Corporation, plc (NYSE:ELN): Elan Corporation, plc today announced that the

US Food and Drug Administration (FDA) has approved PRIALT® (ziconotide

intrathecal infusion) for the management of severe chronic pain in patients for

whom intrathecal (IT) therapy is warranted, and who are intolerant of or

refractory to other treatment, such as systemic analgesics, adjunctive therapies

or IT morphine. FDA approval of PRIALT was based on the treatment of more than

1,200 patients and three Phase III clinical trials, which evaluated the efficacy

and safety of IT PRIALT in patients with severe chronic pain that was not

adequately managed despite a regimen of systemic and/or IT analgesic and other

drugs.

" PRIALT is an innovative new treatment and an important therapeutic advance for

patients who suffer from severe chronic pain, " said Lars Ekman, MD, PhD,

executive vice president and president, Research and Development, Elan. " The

first new IT analgesic approved in more than two decades, PRIALT offers an

important new option for physicians and patients, based on one of the largest

and most comprehensive IT analgesic safety databases available. "

PRIALT, developed by scientists at Elan, is in a class of non-opioid analgesics

known as N-type calcium channel blockers. PRIALT is the synthetic equivalent of

a naturally occurring conopeptide found in a marine snail known as Conus magus.

Research suggests that PRIALT's novel mechanism of action works by targeting and

blocking N-type calcium channels on nerves that ordinarily transmit pain

signals.

" Taken together, the findings from the PRIALT clinical trials are conclusive

evidence that this therapy represents a significant treatment option for

patients who do not have adequate pain relief from other therapies, " said Mark

Wallace, MD, Associate Professor of Clinical Anesthesiology, Department of

Anesthesiology, University of California San Diego; Director, Center for Pain

and Palliative Medicine; and an investigator for PRIALT pivotal studies. " The

extensive body of research that we now have on PRIALT demonstrates that we can

provide significant relief for patients suffering from severe chronic pain that

warrants intrathecal therapy. Furthermore, PRIALT is not associated with the

risk of addiction. "

PRIALT is expected to be available to physicians and patients in the United

States in late January. Pricing will be published at that time.

The approval of PRIALT was based on three independent pivotal trials, which

successfully used the VASPI as the primary endpoint in each study.

" Chronic pain is one of the great hidden health crises of our time, made all the

more urgent by the fact that treatment has long been limited mainly to opioid

medications that may be inadequate or inappropriate for many patients, " said

Pat Aardrup, executive director, National Pain Foundation. " The approval of

PRIALT is part of a new chapter in the management of severe chronic pain that

warrants IT therapy. Patients and physicians across the country will be

encouraged by the approval of this promising new treatment option. "

Results of the PRIALT Slow-Titration Pivotal Trial

The most recent Phase III trial was conducted in response to the FDA's

approvable letter in 2001, which requested additional data using lower doses and

a slower titration. This randomized double-blind, placebo-controlled study was

conducted at 39 sites in the U.S. 220 adults with opioid-resistant, severe

chronic pain were enrolled into this study for up to nine weeks. Most of the

patients had neuropathic pain. All patients had programmable IT infusion systems

and were randomized to receive IT PRIALT (n=112) or placebo (n=108). At

baseline, the mean Visual Analog Scale of Pain Intensity (VASPI) score, the most

commonly used pain assessment scale for clinical trials, for both placebo and

PRIALT groups was 80.7 mm. (VASPI score of 0 mm = no pain; 100 mm = worst

possible pain). Treatment was initiated at 2.4 mcg/day (0.1 mcg/hour) and was

increased by less than or equal to 2.4 mcg/day (less than or equal to 0.1

mcg/hour), no more than two to three times a week for three weeks.

The primary efficacy measure was mean percent change in the VASPI score at week

three, which showed statistically significant improvement in patients receiving

PRIALT vs. placebo (p=0.036). Improvement in VASPI score was seen as early as

week one. The mean dose at week three was 6.9 mcg/day (0.29 mcg/hour). The

majority of secondary efficacy endpoints also showed statistically significant

improvement in patients receiving PRIALT.

The majority of adverse events were mild or moderate. The four most frequently

reported adverse events in this clinical trial were dizziness, ataxia (unsteady

walking), confusion, and abnormal gait (difficulty walking). Study

discontinuation amongst the PRIALT group due to adverse events was comparable

with that for placebo (5.4 percent and 4.6 percent, respectively).

The data from this study will be presented at a major scientific pain meeting

next year.

Previous PRIALT Pivotal Trials

In two other Phase III clinical trials, IT-administered PRIALT was found to

significantly reduce severe chronic pain in a variety of opioid-resistant

patient populations with neuropathic pain and pain related to cancer and AIDS.

The results of the first fast-titration study were published earlier this year

in the Journal of the American Medical Association (January 7, 2004, Vol. 291,

No. 1).

PRIALT Safety

PRIALT has been evaluated as an IT infusion in more that 1,200 patients

participating in chronic pain trials. The longest treatment duration to date is

more than seven years. Severe psychiatric symptoms and neurological impairment

may occur during treatment with PRIALT. Patients with a pre-existing history of

psychosis should not be treated with PRIALT. All patients should be monitored

frequently for evidence of cognitive impairment, hallucinations, or changes in

mood or consciousness. PRIALT therapy can be interrupted or discontinued

abruptly without evidence of withdrawal effects in the event of serious

neurological or psychiatric signs or symptoms.

The four most frequently reported adverse events associated with PRIALT were

dizziness, nausea, confusion, and headache. When PRIALT was used with an

external pump, there was a higher incidence of meningitis.

About PRIALT

PRIALT, developed by scientists at Elan, is the synthetic equivalent of a

naturally occurring conopeptide found in a marine snail known as Conus magus.

PRIALT is administered through appropriate programmable microinfusion pumps that

can be implanted or external, and which release the drug into the fluid

surrounding the spinal cord. Elan filed a Marketing Authorisation Application

for PRIALT with European regulatory authorities in May 2003 and received a

positive recommendation from the European Committee for Medicinal Products for

Human Use in November 2004. A final decision by European regulators is expected

in the first quarter of 2005.

Information about PRIALT, including prescribing information and comprehensive

support services, is available through a toll-free number, 1-888-PRIALT-1, and

at http://www.PRIALT.com.

About Severe Chronic Pain

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

multiple causes, such as failed back surgery, injury, accident, cancer, AIDS,

and other nervous system disorders.

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.