Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu.

Linaclotide.

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services.

Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.

Canagliflozin.

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services.

Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu.

Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate tablets.

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services.

Evidence for treatable inborn errors of metabolism in a cohort of 187 Greek patients with autism spectrum disorder (ASD).

We screened for the presence of inborn errors of metabolism (IEM) in 187 children (105 males; 82 females, ages 4-14 years old) who presented with confirmed features of autism spectrum disorder (ASD). Twelve patients (7%) manifested increased 3-hydroxyisovaleric acid (3-OH-IVA) excretion in urine, and minor to significant improvement in autistic features was observed in seven patients following supplementation with biotin. Five diagnoses included: Lesch Nyhan syndrome (2), succinic semialdehyde dehydrogenase (SSADH) deficiency (2), and phenylketonuria (1) (2.

Motor and speech disorders in classic galactosemia.

Purpose To test the hypothesis that children with classic galactosemia and speech disorders are at risk for co-occurring strength and coordination disorders. Method This is a case-control study of 32 children (66% male) with galactosemia and neurologic speech disorders and 130 controls (50% male) ages 4-16 years. Speech was assessed using the Percentage of Consonants Correct (PCC) metric from responses to the Goldman-Fristoe Test of Articulation-2 and from a 5-min recorded speech sample, hand and tongue strength using the Iowa Oral Performance Instrument, and coordination using the Movement Assessment Battery for Children.

Systematic individual differences in sleep homeostatic and circadian rhythm contributions to neurobehavioral impairment during sleep deprivation.

Individual differences in vulnerability to neurobehavioral performance impairment during sleep deprivation are considerable and represent a neurobiological trait. Genetic polymorphisms reported to be predictors have suggested the involvement of the homeostatic and circadian processes of sleep regulation in determining this trait. We applied mathematical and statistical modeling of these two processes to psychomotor vigilance performance and sleep physiological data from a laboratory study of repeated exposure to 36 h of total sleep deprivation in 9 healthy young adults.

The efficacy of a restart break for recycling with optimal performance depends critically on circadian timing.

Objectives: Under simulated shift-work conditions, we investigated the efficacy of a restart break for maintaining neurobehavioral functioning across consecutive duty cycles, as a function of the circadian timing of the duty periods.

Design: As part of a 14-day experiment, subjects underwent two cycles of five simulated daytime or nighttime duty days, separated by a 34-hour restart break. Cognitive functioning and high-fidelity driving simulator performance were tested 4 times per day during the two duty cycles.

MicroRNA 132 alters sleep and varies with time in brain.

MicroRNA (miRNA) levels in brain are altered by sleep deprivation; however, the direct effects of any miRNA on sleep have not heretofore been described. We report herein that intracerebroventricular application of a miRNA-132 mimetic (preMIR-132) decreased duration of non-rapid-eye-movement sleep (NREMS) while simultaneously increasing duration of rapid eye movement sleep (REMS) during the light phase. Further, preMIR-132 decreased electroencephalographic (EEG) slow-wave activity (SWA) during NREMS, an index of sleep intensity.

Effects of strength training on neuromuscular facial rehabilitation.

Objective: Physical trauma is the third leading cause of facial nerve damage, which can disrupt communication, social interaction and emotional expression. The objective of this report was to investigate the effects of facial muscle exercise as a stand-alone treatment in a young adult with unilateral facial nerve damage 13-years post-onset.

Method: This single case study examines the long-term results of a 7-week intensive facial exercise programme followed by a 16-week moderate facial exercise programme.

The use of simulation in training graduate students to perform transnasal endoscopy.

A challenge facing the field of speech-language pathology is how to equip students at the university level with the transnasal endoscopy skills needed to perform fiberoptic endoscopic evaluation of swallowing (FEES). The use of simulation has the potential to allow students to gain transnasal endoscopy experience with repetitive practice without compromising patients. The present study examined the effects of two different forms of simulation training on multiple transnasal endoscopic passes on healthy volunteers by graduate student clinicians as measured by procedure duration and confidence ratings.

Voice disorders in children with classic galactosemia.

Children with classic galactosemia are at risk for motor speech disorders resulting from disruptions in motor planning and programming (childhood apraxia of speech or CAS) or motor execution (dysarthria). In the present study of 33 children with classic galactosemia, 21% were diagnosed with CAS, 3% with ataxic dysarthria, and 3% with mixed CAS-dysarthria. Voice disorders due to laryngeal insufficiency were common in children with dysarthria and co-occurred with CAS.

Validation of a posturographic approach to monitor sleepiness.

Sleepiness is a major risk factor in traffic- and occupational accidents. While sleepiness is a persistent concern, there is no convenient test to monitor impending levels of sleepiness. We show that force platform posturographic balance testing addresses this need because it estimates time awake (TA) accurately and precisely.

Principal component analysis detects sleepiness-related changes in balance control.

Computerized posturography exploits balance scores that quantify the size, dynamics, or structure of the recorded sway. Since people employ different balance strategies, one single balance score will not detect balance changes in all subjects. Principal component analysis (PCA) can combine balance scores that quantify different features into one new balance score.

Certolizumab pegol for the treatment of Crohn's disease.

Certolizumab pegol is a polyethylene glycolated FAb' fragment of a humanized anti-TNF-alpha monoclonal antibody. This pegylated molecule binds with circulating TNF-alpha and forms an inactive complex that is then eliminated from the body. The drug has been shown to be better than placebo in the treatment of Crohn's disease and maintaining a clinical response in adult patients with moderate-to-severe active disease who have had an inadequate response to conventional therapy, and the treatment of adults with moderately to severely active rheumatoid arthritis.

Advances in the treatment of Raynaud's phenomenon.

Raynaud's phenomenon is a common condition characterized by vasospasm of the digital arteries and resulting cyanosis and redness. It often does not require pharmacologic management, but in some cases symptoms are severe and pharmacologic management is necessary. Calcium channel blockers are often used first-line, but in some patients are ineffective.

Effects of sleep deprivation on dissociated components of executive functioning.

Study Objectives: We studied the effects of sleep deprivation on executive functions using a task battery which included a modified Sternberg task, a probed recall task, and a phonemic verbal fluency task. These tasks were selected because they allow dissociation of some important executive processes from non-executive components of cognition.

Design: Subjects were randomized to a total sleep deprivation condition or a control condition.

Individual differences in vulnerability to sleep loss in the work environment.

There are considerable individual differences in cognitive performance deficits resulting from extended work hours and shift work schedules. Recent progress in sleep and performance research has yielded new insights into the causes and consequences of these individual differences. Neurobiological processes of sleep/wake regulation underlie trait individual variability in vulnerability to performance impairment due to sleep loss.

Maximal tongue strength in typically developing children and adolescents.

Evaluating tongue function is clinically important as the generation of adequate pressure by the anterior tongue against the hard palate is crucial for efficient oropharyngeal swallowing. Research in the evaluation of tongue function in pediatric populations is limited due to questions about the reliability of children's performance on objective measures of tongue strength and the lack of comparative data from typically developing children. The present study examined tongue strength in 150 children and adolescents, 3-16 years of age, with no history of speech or swallowing disorders using the Iowa Oral Pressure Instrument (IOPI).

Feasibility and reliability of remote assessment of PALS psychomotor skills via interactive videoconferencing.

Aim: This study determined inter-rater agreement between skill assessments provided by on-site PALS evaluators with ratings from evaluators at a remote site viewing the same skill performance over a videoconferencing network. Judgments about feasibility of remote evaluation were also obtained from the evaluators and PALS course participants.

Methods: Two remote and two on-site instructors independently rated performance of 27 course participants who performed cardiac and shock/respiratory emergency core cases.

Certolizumab pegol: a polyethylene glycolated Fab' fragment of humanized anti-tumor necrosis factor alpha monoclonal antibody for the treatment of Crohn's disease.

Certolizumab pegol offers an alternative to the other biologic response modifiers for the treatment of Crohn's disease. Results from phase II dose-ranging studies were mixed because a number of the studies had high placebo response rates and a large number of patients with low C-reactive protein (CRP) levels. Phase III clinical trials have demonstrated induction of clinical responses and maintenance of remission for patients independent of whether baseline CRP levels were normal or elevated.

Oral and manual force control in preschool-aged children: is there evidence for common control?

The authors examined and compared the development of oral and manual force control in preschool-aged children. In all, 50 typically developing children (aged 3-5 years) performed maximal strength tasks and submaximal visually guided tasks using tongue elevation, power, and precision grips. Dependent measures included strength, rate of force rise, initial force overshoot, force variability, and rate of force release.