April 28, 2021
The U.S. FDA has approved a new indication for Natroba™ (spinosad) topical solution 0.9%, manufactured by ParaPRO, to treat scabies infestations in patients who are at least four years old.
Scabies infestations occur when Sarcoptes scabiei, a type of mite, burrows into the skin to live and lay its eggs. The infestation usually spreads through prolonged skin-to-skin contact with someone who already has scabies, though it can also spread when sharing clothing or linens (such as sheets or bath towels) with someone who has scabies. The condition usually passes between sexual partners and/or members of the same household. Symptoms include intense itchiness, a pimple-like skin rash, and in some cases thick crusts of skin (crusted scabies). Crusted scabies is often more contagious and requires quick, aggressive treatment to prevent the mites from spreading.
In one clinical trial, Natroba delivered a complete scabies cure at day 28 in 69.8% of patients compared to 46.5% of patients treated with vehicle (a formulation of the topical solution without the active pharmaceutical ingredient). A second clinical trial delivered results of 83.9% of patients achieving a complete cure at day 28 on Natroba versus 34.5% of patients treated with vehicle.
Under the recommended dosing, Natroba should be shaken well in the bottle, then applied to the skin to treat scabies. There should be complete coverage from the neck down to the soles of the feet. If the patient has a balding scalp, Natroba should also be applied to the scalp, hairline, temples, and forehead. For pediatric patients, Natroba application must be directly supervised by an adult. All patients should allow the product to absorb into the skin and dry for 10 minutes before getting dressed and leave Natroba on the skin for at least six hours before showering or bathing. In addition to treating the patient for scabies with Natroba, the household should dry clean or wash in hot water any bedding, clothing, and towels used by anyone who has scabies.
First FDA approved in 2011, Natroba is also indicated to treat head lice infestations in patients who are at least six months old.