Weekly Pharmacology News Round-Up: June 8th – June 14th 2018

This week’s clinical pharmacology highlights include a new treatment for river blindness, further success for JAK inhibitors in inflammatory diseases, and the finding that more patients are taking medications associated with depressive symptoms.

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FDA Approvals

Moxidectin – River Blindness

  • June 13th: The FDA has approved the antihelminthic agent Moxidectin – a glutamate receptor (GluCl) and GABAA receptor modulator – for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus infection in patients aged 12+.  Moxidectin was previously approved only for veterinary use. 

Suboxone Generic – Opioid Use Disorder

  • June 13th: The FDA has approved a generic buprenorphine/naltrexone (Suboxone) sublingual film for the treatment of opioid use disorder.  Generic sublingual buprenorphine/naltrexone sublingual tablets have been available for several years.

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Clinical Trials

Upadacitinib – RA

  • June 13th, The Lancet:  Two phase III trials (SELECT-NEXT & SELECT-BEYOND) of upadacitinib, a selective JAK1 inhibitor for the treatment of refractory rheumatoid arthritis showed efficacy and a reasonable safety profile. Randomized-placebo controlled.

Baricitinib – SLE

  • June 14th, Annual European Congress of Rheumatology: A phase II clinical trial of baricitinib (JAK1/JAK2 inhibitor) has demonstrated efficacy in the treatment of systemic lupus erythematosus.  Randomized-placebo controlled.

Ozenoxacin – Impetigo

  • June 13th, JAMA Dermatology:  A phase III trial showed Ozenoxacin (non-fluorinated quinolone antibiotic) 1% topical cream is safe and efficacious in childhood impetigo infection.  Drug was approved last year for impetigo, based in part on these results. Randomized-placebo controlled.

Aramchol – NASH

  • June 12th, Galmed Pharmaceutical: A phase II clinical trial of aramchol (SCD1 modulator) showed efficacy in treating non-alcoholic steatohepatitis (NASH) and will likely move to Phase III trials.  Randomized placebo-controlled.

Amisulpride – Nausea

  • June 14th, Anesthesiology: A clinical trial has demonstrated that IV administration of the antipsychotic amisulpride (a dopamine antagonist) alongside a second antiemetic is effective in preventing post-op nausea & vomiting.  Randomized placebo-controlled.

 

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Clinical Pharmacology Research

Antibiotics – Appendicitis

  • June 13th, Annals of Surgery: A cohort study found that narrow-spectrum antibiotics are just as effective as broad spectrum antibiotics (e.g., pip-tazo) in children with uncomplicated appendicitis. Observational retrospective cohort.

Fluconazole – Stillbirth

  • June 13th, JAMA:  A study observed that oral fluconazole use in pregnancy did not significantly increased risk of stillbirth or neonatal death.  Observational retrospective cohort.

Medications – Depression

  • June 12th, JAMA:  A population study found that 37% of patients (from NHANES database) use medications associated with causing depressive symptoms. Observational cross-sectional.

Betamethasone – Cardiometabolic Outcomes

  • June 9th, Pediatrics: The ACTORDS trial demonstrated that antenatal betamethasone (steroid used for accelerating fetal organ development) in women at risk for pre-term birth was not associated with adverse childhood cardiometabolic outcomes, and may have a beneficial effect on height.  Randomized-controlled.

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by pharmacologyreview

 

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