Trends in the approval of cancer therapies by the FDA in the twenty-first century.

The cancer treatment landscape has changed dramatically since the turn of the century, resulting in substantial improvements in outcomes for patients. This Review summarizes trends in the approval of oncology therapeutic products by the United States Food and Drug Administration (FDA) from January 2000 to October 2022, based on a categorization of these products by their mechanism of action and primary target. Notably, the rate of oncology indication approvals has increased in this time, driven by approvals for targeted therapies, as has the rate of introduction of new therapeutic approaches.

Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.

Objective: Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment.

Method: Results were derived from the study of 384 patients (125 patients remaining in the open-label trial since the interim report), receiving up to 221 weeks of treatment.

Atomoxetine treatment of adults with ADHD and comorbid alcohol use disorders.

Objective: Adults with attention-deficit/hyperactivity disorder (ADHD) have higher rates of alcohol and drug use disorders than adults without ADHD. The study aim was to determine if atomoxetine was superior to placebo in improving ADHD and alcohol use in recently abstinent adults with ADHD and comorbid alcohol use disorder.

Methods: Adults with DSM-IV diagnoses of ADHD and alcohol abuse and/or dependence were abstinent from alcohol at least 4 days (maximum 30 days) before study randomization.

Abuse liability assessment of atomoxetine in a drug-abusing population.

Background: Atomoxetine is a non-amphetamine medication approved to treat ADHD in children, adolescents, and adults. Previous studies demonstrated low abuse potential for atomoxetine in recreational drug users. This study assessed the abuse potential of atomoxetine in stimulant-preferring drug abusers compared to methylphenidate and phentermine as positive controls and desipramine and placebo as negative controls.

Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder: acute comparison and differential response.

Objective: Response to atomoxetine, a nonstimulant norepinephrine-specific reuptake inhibitor, was compared with the effect of osmotic-release oral methylphenidate, a long-acting methylphenidate preparation, in patients with attention deficit hyperactivity disorder (ADHD).

Method: In a large placebo-controlled, double-blind study, patients ages 6-16 with ADHD, any subtype, were randomly assigned to receive 0.8-1.

Atomoxetine for the treatment of attention-deficit/hyperactivity disorder and oppositional defiant disorder.

Objective: In this study we examined the effectiveness of atomoxetine for the treatment of oppositional defiant disorder comorbid with attention-deficit/hyperactivity disorder.

Methods: Patients were aged 6 to 12 years and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnostic criteria for attention-deficit/hyperactivity disorder with a Swanson, Nolan, and Pelham Rating Scale-Revised attention-deficit/hyperactivity disorder subscale score above age and gender norms; Clinical Global Impressions-Severity Scale score of > or = 4; and Swanson, Nolan, and Pelham Rating Scale-Revised oppositional defiant disorder subscale score of > or = 15. Patients were randomly assigned in a 2:1 ratio to receive 1.

High-dose atomoxetine treatment of ADHD in youths with limited response to standard doses.

Objective: To assess the utility and tolerability of higher than standard atomoxetine doses to treat attention-deficit/hyperactivity disorder (ADHD).

Method: Two randomized, double-blind trials of atomoxetine nonresponders ages 6 to 16 years were conducted comparing continued treatment with same-dose atomoxetine to treatment using greater than standard efficacious doses (study 1: up to 3.0 mg .

Quality of life assessment in adult patients with attention-deficit/hyperactivity disorder treated with atomoxetine.

Background: Attention-deficit/hyperactivity disorder (ADHD) has its onset during childhood and is estimated to affect 3% to 7% of school-aged children. Unfortunately, the disorder frequently persists into adult life. The burden of this disorder is considerable and is often characterized by academic (or occupational) impairment and dysfunction within the family and society.

Low-dose atomoxetine for maintenance treatment of attention-deficit/hyperactivity disorder.

Objective: Data from acute studies of atomoxetine in patients with attention-deficit/hyperactivity disorder suggest that a dose of approximately 1.2 mg/kg per day is required to attain a maximal symptom response. However, lower doses could be effective during maintenance treatment, which would reduce drug exposure and potential problems related to tolerability during chronic treatment.

Long-term, open-label study of the safety and efficacy of atomoxetine in adults with attention-deficit/hyperactivity disorder: an interim analysis.

Background: Attention-deficit/hyperactivity disorder (ADHD) is an early-onset neuropsychiatric disorder that affects 3% to 7% of school-age children and 4% of adults. Its pathophysiology is thought to involve the dopaminergic and nor-adrenergic pathways associated with attention control and impulsivity. These symptoms have largely been defined in the childhood population, but the course of the condition and expression in the adult population are not as well characterized.

Direct Raman imaging techniques for study of the subcellular distribution of a drug.

Direct Raman imaging techniques are demonstrated to study the drug distribution in living cells. The advantage of Raman imaging is that no external markers are required, which simplifies the sample preparation and minimally disturbs the drug mechanism during imaging. The major challenge in Raman imaging is the weak Raman signal.

Preclinical antitumor activity and pharmacokinetics of methyl-2-benzimidazolecarbamate (FB642).

Methyl-2-benzimidazolecarbamate (carbendazim, FB642) is an anticancer agent that induces apoptosis of cancer cells. In vitro, FB642 demonstrated potent antitumor activity against both the murine B16 melanoma (IC50 = 8.5 microm) and human HT-29 colon carcinoma (IC50 = 9.

Effects of cocaine self-administration on striatal dopamine systems in rhesus monkeys: initial and chronic exposure.

The purpose of this study was to examine the time course of changes in dopamine D(1)- and D(2)-like receptor densities in monkeys self-administering cocaine. Experimentally naïve adult male rhesus monkeys (n = 22) were divided into a food reinforcement group (n = 6), in which responding was maintained by food presentation, or into four cocaine self-administration groups (n = 4/group), based on dose (0.03 or 0.

Ethnographic methodologic assessment of pain perceptions by verbal description.

This study was designed to use known anthropologic methods to gather and analyze qualitative data about verbal descriptors of pain among 25 Chinese, and 60 Western subjects (25 Anglo-Americans and 35 Scandinavians). The sample consisted of 54 patients and 31 dentists. Key pain descriptors from each cultural context were selected for construction of pain assessment instruments which allowed multidimensional statistical techniques to translate these data into cross-cultural quantitative indices.