Expert opinion on investigational drugs
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Fentanyl buccal tablets (FBT) are designed to manage the breakthrough pain associated with chronic pain with an enhanced rate and extent of fentanyl absorption through the buccal mucosa. The formulation incorporates an effervescent reaction to produce large shifts in pH that enhance absorption. Results from studies of safety and tolerability have shown FBT to be effective and well tolerated in opioid-tolerant chronic pain patients. ⋯ Adverse events were common but mild or moderate in most cases and did not cause a high drop-out rate. In addition to the treatment of breakthrough pain, FBT could be clinically efficacious for the treatment of brief, anticipated painful events. The abuse liability of FBT is unknown and caution should be used in prescribing FBT to patients with histories of substance abuse.
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This perspective is the second in a series of papers discussing drugs dropped from development in 2005, of which 20 were being developed for cancer. Of these 20, 60% were biological agents and included 3 cancer vaccine (e.g., Canvaxin) and 2 antisense oligonucleotide (e.g., aprinocarsen sodium). Overall, 10 cancer drugs were discontinued in Phase I, 6 in Phase II and 4 at Phase III. This paper surveys drugs discontinued in the oncology arena in 2005 by stage of development and class of compound, suggesting some reasons for their failure.