Spinosad

Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.

• Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. ( 1.1 ) Spinosad Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older.ICD-10: B85.0, B86

• None. None.contraindicated

For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Treatment of head lice infestations ( 2.2 ): Shake bottle well Apply a sufficient amount to cover dry scalp, then apply to dry hair Rinse off with warm water after 10 minutes Repeat treatment only if live lice are seen 7 days after first treatment Treatment of scabies infestations ( 2.3 ): Shake bottle well Apply product to skin by rubbing it in to completely cover the body from the neck down to the soles of the feet Patients with balding scalp should also apply product to the scalp, hairline, temples, and forehead Allow to absorb in the skin and dry for 10 minutes before getting dressed Leave on the skin for at least 6 hours before showering or bathing 2.1 Important Administration Instructions For topical use only. Spinosad Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. If Spinosad Topical Suspension gets in or near the eyes, rinse thoroughly with water. 2.2 Treatment of Head Lice Infestations Shake bottle well. Apply a sufficient amount of Spinosad Topical Suspension to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair. Leave on for 10 minutes, then thoroughly rinse off with warm water. Wash hands after use. If live lice are seen 7 days after the first treatment, a second treatment should be applied. Apply Spinosad Topical Suspension on pediatric patient only under direct supervision of an adult [see Warnings and Precautions (5.1) ].

Benzyl Alcohol Toxicity: Not recommended in infants below the age of 6 months; potential for increased systemic absorption. ( 5.1 ) 5.1 Benzyl Alcohol Toxicity Spinosad Topical Suspension contains benzyl alcohol and is not approved for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants when administered intravenously [See Use in Specific Populations (8.4) ] .

Most common adverse events for lice treatment (>1%) were application site erythema and ocular erythema. ( 6.1 ) Most common adverse reactions for scabies treatment (>1%) were application site irritation (pain and burning) and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ParaPRO LLC at 1-855-628-7622 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Head Lice Infestations Spinosad Topical Suspension was studied in two randomized, active-controlled trials (N=552) in subjects with head lice; Table 1 presents selected adverse events, regardless of relationship to Spinosad Topical Suspension, that occurred in at least 1% of subjects. Table 1: Selected Adverse Events Occurring in at least 1% of Subjects with Head Lice Infestation Signs Spinosad (N=552) Permethrin 1% (N=457) Application site erythema 17 (3%) 31(7%) Ocular erythema 12 (2%) 15 (3%) Application site irritation 5 (1%) 7 (2%) Other less common reactions (less than 1% but more than 0.1%) were application site dryness, application site exfoliation, alopecia, and dry skin.

8.1 Pregnancy Risk Summary Spinosad, the active ingredient in Spinosad Topical Suspension, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug. Spinosad Topical Suspension contains benzyl alcohol. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug [ see Clinical Pharmacology (12.3) ]. In animal reproduction studies, no adverse embryofetal effects were seen at oral doses of spinosad up to 200 mg/kg/day in pregnant rats or 50 mg/kg/day in pregnant rabbits administered during the period of organogenesis ( see Data ). The available data do not allow the calculation of relevant comparisons between the systemic exposure of spinosad in animal studies to the systemic exposure that would be expected in humans after topical use of Spinosad Topical Suspension. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk for birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

Head Lice Infestations An open-label, single-center trial was conducted over a period of seven days to determine the pharmacokinetic profile of spinosad 1.8% in pediatric subjects with head lice infestation. Fourteen (14) subjects, 4 – 15 years of age, with head lice were enrolled into the trial.

No specific antidotes for spinosad overdosage are known. If oral ingestion occurs, contact Poison Control (1-800-222-1222) for latest recommendations and seek medical attention immediately.

• Jan 18, 2011NDANDA022408Cipher

1. 1Drug Ineffective1533%
2. 2Pruritus716%
3. 3Alopecia511%
4. 4Rash48.9%
5. 5Condition Aggravated36.7%
6. 6Erythema36.7%
7. 7Abdominal Pain Upper24.4%
8. 8Burning Sensation24.4%
9. 9Death24.4%
10. 10Headache24.4%
11. 11Lice Infestation24.4%
12. 12Paraesthesia24.4%
13. 13Product Quality Issue24.4%
14. 14Seizure24.4%
15. 15Sleep Disorder24.4%

The 10 most recently updated of 11 ClinicalTrials.gov registrations naming Spinosad as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis.
  Active not recruiting · Phase 2 · Interventional · 100 enrolled · Aperta Biosciences, LLC
  NCT06720896updated 2026-05-19
• PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
  Unknown · Phase 4 · Interventional · 50 enrolled · Cipher Pharmaceuticals Inc.
  NCT05310734updated 2025-02-14
• Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
  Completed · Phase 3 · Interventional · 280 enrolled · ParaPRO LLC
  NCT02485704updated 2021-05-21
• Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
  Completed · Phase 3 · Interventional · 291 enrolled · ParaPRO LLC
  NCT02485717updated 2021-05-19
• A Pilot Dose Ranging Study of Spinosad Creme Rinse
  Completed · Phase 2 · Interventional · 36 enrolled · ParaPRO LLC
  NCT00858481updated 2015-10-20
• Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
  Completed · Phase 4 · Interventional · 26 enrolled · ParaPRO LLC
  NCT01660321updated 2012-11-22
• Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
  Completed · Phase 3 · Interventional · 480 enrolled · ParaPRO LLC
  NCT00545168updated 2012-10-11
• Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice
  Completed · Phase 3 · Interventional · 558 enrolled · ParaPRO LLC
  NCT00545753updated 2012-10-11
• NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
  Completed · Phase 1 · Interventional · 65 enrolled · ParaPRO LLC
  NCT00605956updated 2008-08-04
• Phototoxicity Potential of NatrOVA Creme Rinse - 1%
  Completed · Phase 1 · Interventional · 37 enrolled · ParaPRO LLC
  NCT00591331updated 2008-05-20

Frequently asked questions

How does Spinosad work?

Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.

What is Spinosad used for?

According to FDA labeling, Spinosad carries indications including: Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in adult and pediatric patients 6 months of age and older. ( 1.1 ) Spinosad Topical Suspension is a scabicide indicated for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Spinosad?

Spinosad is classified as Pediculicide, Nervous System Activity Alteration.

What are the brand names for Spinosad?

Spinosad is marketed under brand names including Comfortis, Natroba, Trifexis.

What are the contraindications for Spinosad?

Spinosad labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.