In a 220-patient, randomized, double blind, placebo-controlled, phase III investigation, Prialt met its primary endpoint in patients with severe, chronic pain whose refractory pain included failed trials of intrathecally delivered morphine. To address FDA concerns, this trial studied lower Prialt doses at a slower titration schedule than was used in two previous phase III investigations. Prialt recipients achieved statistically significant improvement at week 3 in terms of the Visual Analog Scale of Pain Intensity (VASPI) score, a well-validated pain assessment scale. The overall safety, tolerability, and efficacy profiles should lead to a successful amendment to Prialt’s NDA to be submitted in the second quarter of 2004. Élan would like to market Prialt beginning “no later than the first quarter of 2005.” Élan plans to seek approval to provide Prialt to highly selected patients at specific U.S. pain centers “in the first quarter of 2004.” Relevant data is expected “at a major scientific pain meeting this year.”

Adding to the Prialt buzz are data from the JAMA paper. A 111-enrollee, double-blind, placebo-controlled trial randomly assigned (2:1) highly-refractory subjects to receive ziconotide or placebo in addition to standard analgesia to which they were refractory. Intrathecal Prialt was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment arm. 68 evaluable study subjects generated compelling data demonstrating clinically and statistically significant Prialt advantages in terms of:

• mean VASPI score improvement (53.1% vs. 18.1%, p<.001)
• percentage of patients experiencing moderate to complete pain relief (52.9% vs. 17.5%, p<.001; 5 Prialt recipients achieved complete pain relief)
• response to therapy (50.0% versus 17.5%, p = .001).

Prialt’s adverse effect profile appeared predictable and manageable. Multiple completed and ongoing trials should clarify the overall risk-benefit profile of Prialt.

Pain is the number one reason for doctor visits in the United States. More than 100 million North Americans are estimated to suffer from chronic pain, with about half partially or totally disabled by chronic, intractable, or long-term pain. Chronic pain costs business and industry approximately 70 million workdays per year resulting in annual, indirect costs to society in excess of $60 billion. Prialt was developed from the paralyzing venom of a marine snail. It targets the areas where pain nerves enter the spine, effectively blocking pain signals from carrying pain sensation up the spinal tract to the brain. Opiates currently dominate the market for chronic, intractable pain. Prialt equidose treatment effect appears to parallel that of opiates. Milligram per milligram dosing makes it on the order of 10,000 times as potent as a mid-range opiate. Additionally, Prialt lacks the problem of tolerance, the physiological requirement for more drug to maintain the same level of perceived effect over time, often until maximum dose no longer produces effect. This advantage may eventually prove to be a key use driver for Prialt in the real world for various clinical and psychosocial reasons. Whether Prialt delivery issues arise as the agent moves from clinical trial to real-world settings remains to be seen.

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