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.
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Expert Opin Investig Drugs · Jul 2006
ReviewPirfenidone for the treatment of idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis (IPF) is an under-recognised, rare, progressive disease of the lungs with unknown aetiology and high mortality. The currently advocated pathogenic mechanism is represented by progressive multifocal fibrosis. It is diagnosed based on clinical, radiographic, physiological and histopathological criteria. ⋯ There is no therapy approved specifically for IPF, but several antifibrotic agents are currently under development for this indication. Pirfenidone is an antifibrotic agent potentially effective for IPF therapy, and preclinical and available clinical data support its use in IPF. Future clinical studies are expected to provide more consistent information on survival benefit, lung function and health-related quality of life.
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Expert Opin Investig Drugs · Jun 2006
ReviewPharmacological treatment of attention-deficit/hyperactivity disorder in adults.
With increased awareness that attention-deficit/hyperactivity disorder (ADHD) can persist beyond childhood, pharmacological treatment options for adults have expanded. Short-acting stimulants continue to be the first-line approach, demonstrating clinical efficacy and few adverse events in well-controlled trials, with long-acting stimulants also showing promise. ⋯ Data are limited in evaluating the impact of combining pharmacological treatments for ADHD and comorbid conditions. This paper describes the safety and efficacy of medications for treating the core symptoms, psychosocial features and cognitive dysfunctions associated with adult ADHD.
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Expert Opin Investig Drugs · May 2006
ReviewMethylnaltrexone, a novel peripheral opioid receptor antagonist for the treatment of opioid side effects.
Methylnaltrexone is an investigational peripheral opioid receptor antagonist, a quaternary derivative of naltrexone. Methylnaltrexone has greater polarity and lower lipid solubility, thus it does not cross the blood-brain barrier in humans. Methylnaltrexone offers the therapeutic potential to block or reverse the undesired side effects of opioids that are mediated by receptors located in the periphery (e.g., in the gastrointestinal tract), without affecting analgesia or precipitating the opioid withdrawal symptoms that are predominantly mediated by receptors in the CNS. This article reviews preclinical studies and clinical opioid bowel dysfunction trial data, and briefly discusses other potential roles of this compound in clinical practice.