Elan, a relatively small company, has won FDA approval for two novel drugs in two months. In November, the FDA approved its multiple sclerosis drug Tysabri.
Prialt is a synthetic form of the venom that the Conus magus cone snail, which lives in tropical saltwater shallows, uses to stun passing prey.
Efforts to turn the substance into a pill faltered because of its potency, but researchers found that small drips of the drug into the spinal cord fluid went safely to the brain.
In 2000, the FDA required an additional clinical trial to better determine the best dosages, and Ekman said patients will initially receive smaller amounts as a result.
Chris McNeil, a California small-business man who has taken the drug for almost a year as part of a clinical trial, said it has changed his life. He said sharp, unexplained pain in his legs -- and the fog that enveloped him when he took opioid painkillers -- had kept him virtually homebound for six years.
"Once I started taking the new drug, I could walk again and laugh again and start having a life," said McNeil, 48. "I lift heavy boxes in my shop and even play a little soft tennis."
Prialt, which is expected to reach the market next month, will come with a "black box" warning regarding its risks, which include hallucinations and even psychosis in vulnerable people. McNeil said he experienced hallucinations in the first two weeks he was taking the drug, but they stopped.
Despite the limitations of Prialt, Mary Pat Aardrup, executive director of the National Pain Foundation, a nonprofit education group, called yesterday a "red-letter day" for pain patients. "To have another pain drug in an entirely new class is very exciting and very hopeful."