Spinosad

(Natroba®)

Natroba®

Drug updated on 4/10/2024

Dosage FormSuspension (topical; 0.9%)
Drug ClassAntiparasitic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the topical treatment of head lice infestations in adult and pediattic patients 6 months of age and older.
  • For the topical treatment of scabies infestations in adult and pediatric 4 years of age older.

Summary
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  • Spinosad (Natroba) is indicated for the topical treatment of head lice and scabies infestations in adults and pediatric patients, with age restrictions varying between 6 months to 4 years depending on the condition.
  • The study was derived from a randomized controlled trial.
  • In terms of efficacy, Spinosad showed significant results compared to placebo. Approximately 78.1% of the subjects treated with Spinosad achieved complete cure by day 28 post-treatment as opposed to only 39.6% in the placebo group.
  • Safety-wise, no adverse effects were reported among study participants, indicating that it is well-tolerated and safe for use in treating scabies infestations.
  • Although direct comparisons with other treatments are not provided within this study, it suggests potential advantages over approved products due to its natural source, reducing chances of resistance development.
  • The study tested Spinosad on both adult and pediatric patients aged four years or older, suggesting its applicability across various age groups; however, detailed subgroup analysis data isn't available, limiting insight into differential efficacy or safety profiles within subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Natroba (spinosad) Prescribing Information.2021ParaPRO LLC, Carmel, IN

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Spinosad at 0.9% in the treatment of scabies: Efficacy results from 2 multicenter, randomized, double-blind, vehicle-controlled studies.
206Subjects
F: 57%
M: 43%
2022Journal of the American Academy of Dermatology

Sex Distribution:

F:57%
M:43%
206Subjects

Year:

2022

Source:Journal of the American Academy of Dermatology