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FDA Rejects ADHD Drug NDA Citing Want for Extra Information

The treatment was studied in approximately 2500 children and adults with ADHD.

The treatment was studied in approximately 2500 children and adults with ADHD.

Sunovion announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for dasotraline, an investigational treatment for attention-deficit hyperactivity disorder (ADHD). 

Dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), was studied in approximately 2500 children and adults with ADHD. The drug has an extended half-life with 47-77 hours in adults and 58-84 hours in children; this allows for stable plasma concentrations and a sustained clinical effect over 24 hours. 

The NDA for dasotraline, submitted in August 2017, included data from a clinical program that included 4 placebo-controlled safety and efficacy studies, as well as two long-term studies assessing the safety of dasotraline in patients with ADHD for up to one year. The FDA stated that the dasotraline NDA cannot be approved in its current form and is requiring additional data to further assess the efficacy and tolerability of the drug. Sunovion EVP, CEO, Antony Loebel, MD, said, “We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible.”

Dasotraline is also being evaluated as a treatment of moderate to severe binge eating disorder (BED) in adults. Findings from 2 pivotal studies will be included in the application submission to the FDA in fiscal year 2018.

Which Opioids Are Extra More likely to Induce QT Interval Prolongation?


August 07, 2018

Concomitant use of methadone-interacting drugs was also found to increase the risk of QT prolongation and TdP

Concomitant use of methadone-interacting medication was additionally discovered to extend the danger of QT prolongation and TdP

Amongst opioids, methadone seems to hold the very best threat for inducing QT interval prolongation and arrhythmia even at low doses, based on a examine revealed within the journal Medical Rules and Practices.

To evaluate the influence of opioid use on exercise of the center, researchers searched papers revealed as much as 2017 utilizing 20 opioid names together with key phrases akin to ‘QTc’, ‘QT interval’, ‘QT prolongation’, ‘ventricular arrhythmias’, ‘atrial arrhythmias’ ‘hERG’, ‘torsades de pointes (TdP)’ and ‘different associated phrases’.

A 2016 examine (Romero et al.) discovered that methadone was the main reason for TdP amongst 2735 sufferers with extended QT interval who have been taking prescribed drugs. Concomitant use of methadone-interacting medication was additionally discovered to extend the danger of QT prolongation and TdP.  One other examine (Butler et al. 2011) of 14,500 sufferers on methadone upkeep remedy (MMT) discovered that the prime cause for cardiac arrhythmia-related dying was taking different interacting prescribed drugs.

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Research evaluating MMT to buprenorphine upkeep remedy (BMT) over 5-years discovered buprenorphine to be a safer drug for opioid upkeep remedy because it had no important impact on QT prolongation. Increased doses of methadone, Pearson (2005) and Value (2014) concluded, have been ‘seemingly’ to contribute to the magnitude of QT prolongation. Nonetheless, different research (Chowdhury et al. 2015) couldn’t discover a correlation between dose and better prevalence of QT prolongation. Ehret et al. (2006) discovered that TdP occurred in a affected person on a methadone dose as little as 40mg/day.

Oxycodone doses of ≥100mg have been associated to longer QT intervals, main the authors to deem it an ‘intermediate’ threat for arrhythmia, nevertheless they acknowledged that extra analysis was wanted to verify these findings. Restricted research of tramadol point out that it might considerably improve the QT interval however additional analysis can also be wanted to verify this. Morphine was discovered to be ‘low-risk’ at routine doses and research of fentanyl confirmed contradictory outcomes.

The authors concluded that “To scale back arrhythmogenic threat, excessive doses of opioids should be used cautiously with periodic monitoring of electrocardiogram in high-risk customers akin to sufferers below opioid upkeep remedy.”

For extra info go to Krager.com.

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OnabotulinumtoxinA Safer, Extra Efficient for Headache Prevention Than Topiramate


June 29, 2018

This text initially appeared on Neurology Advisor.

Forty percent of patients in the onabotulinumtoxinA group saw a reduction of ≤50% in headache days by 32 weeks.

Forty % of sufferers within the onabotulinumtoxinA group noticed a discount of ≤50% in headache days by 32 weeks.

SAN FRANCISCO — OnabotulinumtoxinA was discovered to be extra tolerable than topiramate for stopping headache, in keeping with analysis introduced on the American Headache Society’s 60th Annual Scientific Assembly, held June 28–July 1, 2018, in San Francisco, California. This randomized, open-label research examined participant reported outcomes, security, and tolerability of onabotulinumtoxinA and topiramate in adults with persistent migraines.

Topics within the onabotulinumtoxinA arm (n=140) acquired a set dose each 12 weeks for 36 weeks, whereas topics within the topiramate arm (n=142) acquired 50 to 100 mg per day as much as 36 weeks. The efficacy finish level, a discount of at the very least 50% in headache days by 32 weeks, was better within the onabotulinumtoxinA arm than the topiramate arm (40% vs 12%).

Security and tolerability have been assessed by opposed occasion stories, a cognitive verbal fluency take a look at, and a depressive symptom questionnaire at baseline, 12, 24, and 36 weeks. Antagonistic occasions have been greater within the topiramate arm (76.eight%) vs onabotulinumtoxinA arm (45.5%), and drop out charges have been greater within the topiramate arm (80.three%) vs the onabotulinumtoxinA arm (14.three%). Nervous system problems have been the most typical purpose for discontinuation within the topiramate arm and cognitive adjustments have been famous on the verbal fluency take a look at as early as 12 weeks. No new security considerations have been famous within the onabotulinumtoxinA arm, and contributors handled with onabotulinumtoxinA even confirmed slight enhancements in cognitive perform and depressive signs.

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The researchers concluded that, “[onabotulinumtoxinA] had a superior tolerability profile versus topiramate based mostly on treatment-related [adverse events] and general discontinuations.”


Blumenfeld A, Patel AT, Zhao X, Adams AM, Rothrock JF. A multicenter, potential, randomized, open-label research to check onabotulinumtoxinA and topiramate for headache prevention in adults with persistent migraine: Affected person reported outcomes from the FORWARD Examine. Introduced at: 2018 American Headache Society Annual Scientific Assembly. June 28-July 1, 2018; San Francisco, CA. Summary 448961.

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