Janssen/Alza fentanyl

Executive Summary

FDA has expressed concern over improper use of Duragesic first generation fentanyl patch product. Janssen is expected to issue a "Dear Doctor" letter to remind medical community of labeled indications. Among current label restrictions is a statement that the product is not recommended for treatment of post-op pain. As Janssen prepares to clarify current product usage, Alza reports to securities analysts on Jan. 13 that the two companies are in clinical trials with a fentanyl product using Alza's electrotransport technology. The new product "will allow a patient to titrate the level of required opioid input to alleviate severe pain through the use of a self-adhesive, disposable, transdermal system." The second generation product is designed for the acute pain market, Alza says...