FDA approves Rx-to-OTC switch for head lice lotion

In non-pandemic years, every parent dreads getting a particular phone call or note from their children’s preschool or elementary school: “Your child has head lice and cannot return to school until it’s been eradicated.” Now parents have an easier option for treating their children and getting rid of pesky head lice, so their kids can go back to the classroom, sooner. 

The U.S. Food and Drug Administration (FDA) has approved a previously prescription-only lotion for over-the-counter (OTC) use to treat head lice. Sklice (ivermectin) is applied to the scalp and hair to kill the lice for 10 minutes before being rinsed thoroughly away with water. 

Six to 12 million cases of head lice occur each year in children between the ages of 3 and 11 years old in the United States, according to the Centers for Disease Control and Prevention (CDC).

This news will be a comfort to all those frustrated parents looking for an effective way to eliminate those tiny parasitic insects and their even tinier eggs, known as nits. 

How the change was made

The 0.5% ivermectin lotion was originally approved by the FDA in 2012 for the use in people ages 6 months and older. It’s manufactured by Arbor Pharmaceuticals, LLC. Prior to this decision, Sklice was only available with a prescription. 

The FDA used its Rx-to-OTC switch process to make this single-use lotion available at the drugstore to patients without a visit to the pediatrician first. 

The approval “expands access to another effective topical treatment for the thousands of people with head lice,” says Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research in a statement.

 The Rx-to-OTC process was designed to increase consumer access to drugs that are usually only available by prescription. According to the FDA, these switches are typically initiated by the drug manufacturers. They must demonstrate that the drug can be used safely if offered without a prescription.

 (Another form of ivermectin in a 1.0% formula continues to require a prescription. This version, which is used in the topical treatment of rosacea, is sold under the brand name Soolantra, from Galderma Laboratories.)

Other head lice treatments

In addition to Sklice, parents can also try these treatment options.

 They can opt for an OTC product shampoo that contains permethrin, an insecticide which is toxic to lice, or a compound known as pyrethrin. Options include:

• Nix: Nix products, which contain permethrin, are available as a shampoo and a cream rinse for hair, as well as the combination product, Nix Ultra® Super Lice Treatment.
• Rid: You can go with Rid Lice Killing Shampoo, or choose the Rid MAX Lice Removal Kit or Rid MAX Complete Kit. The active ingredients in Rid are piperonyl butoxide and pyrethrins.

Or they may prefer to go with a prescription-strength treatment. Your healthcare provider can choose between a pediculicide lotion or a pediculicide shampoo, both of which are intended to kill the lice. Prescription lotions containing pediculicide include: 

• Natroba: Natroba (spinosad) is a topical treatment for head lice that was approved by the FDA in 2011. It typically comes in a 120 mL bottle of a 0.9 percent strength solution. You apply it to the affected person’s dry hair and scalp, let it sit for ten minutes, then rinse it out with warm water.
• Ovide: Ovide (malathion) is another prescription lotion that targets head lice and their eggs, too.
• Lindane: Lindane shampoo is a prescription intended to treat lice.

Before using any lice treatment product, check with your healthcare provider or pharmacist, as some treatments may have age restrictions, or you may need to take certain precautions when using or applying them.