Levadex, MAP Pharmaceuticals’ orally inhaled medication for acute migraine, has met all 4 of the Phase 3 endpoints. In a news release issued on May 26, 2009 MAP Pharmaceuticals stated,
Patients taking LEVADEX therapy (formerly referred to as MAP0004) had statistically significant improvement at two hours compared to patients on placebo for each of the primary endpoints: Pain relief,…Phonophobia… Photophobia,…and Nausea….
Relief from nausea was particularly notable with more than two thirds of the study population gaining relief.
The Phase 3 study population of 792 Migraine sufferers had more severe migraine pain than expected with 100% experiencing moderate or severe pain.
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courtesy of dbtechno.com
This Chicago Tribune story came in my email this morning. In 2000, Diane Levine, who is a musician, was given Demerol and Phenergan for a migraine. Tragically for her, the physician’s assistant injected the Phenergan into an artery instead of a vein. Levine subsequently developed gangrene and had her right forearm amputated. Not suprisingly, she sued the clinic and the physician’s assistant for malpractice and received a $700,000 settlement.
What followed is tragic for all patients. Levine subsequently sued the drug company, Wyeth, for $7 million in damages, stating that there were not enough warnings on the label. In reality, there are 6 warnings indicating that intra-artierial injection can result in gangrene. She won.
The FDA had already approved the warning labels on Phenergan. However, last week, the Supreme Court upheld the Vermont verdict. Unfortunately, and counter to present practice, it appears, in this case, the Court upheld that untrained juries could dictate what drug companies put on their labels instead of trained doctors and pharmacists, who comprise the FDA.
In the end, Diane won her case against Wyeth, but who loses? All of may lose. Migraineurs may lose. They may not want to take a drug out of fear. They may not be given approved, safe drugs for fear of a lawsuit. Drug companies may not develop drugs with severe side effects for fear of a law suit. We all may pay higher prices for drugs that we need. In the end, sick people are inadequately treated. Just like Justice Alito said in his dissent, “tragic facts make for bad law”. This is one of them.
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