Clinical design and competition issues
On the heels of a negative review by FDA's Peripheral and Central Nervous System Drugs Advisory Committee, Cephalon Inc. faces the decision whether to conduct an additional trial of Myotrophin IGF-1 to confirm the positive results of its North American trial in amyotrophic lateral sclerosis.
The company last week said it can't justify the expense of another trial prior to marketing approval, although it has been planning a combination study with Rhone-Poulenc Rorer's Rilutek riluzole, which is the only drug approved for ALS. Whether or not CEPH does another trial will depend on the company's analysis of the cost of a new study versus the size of the market and upcoming competition. But whatever the decision, a brief survey of clinicians indicates they believe it should be possible to design a trial that can show the positive effects of a drug for the disease...