FDA approves nonprescription use of Sklice lotion for head lice

The FDA approved nonprescription Sklice to treat head lice through a process called prescription-to-OTC switch.

Sklice (ivermectin, Arbor Pharmaceuticals) lotion, 0.5% was initially approved by the FDA in February 2012 for the treatment of head lice infestation in patients aged 6 months or older.

According to Theresa Michele, MD, acting director of the FDA’s Office of Nonprescription Drugs, the prescription-to-OTC which process “aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription.”

“[The] approval expands access to another effective topical treatment for the thousands of people with head lice,” Michele said in a press release.

According to the FDA, each year in the United States, there are an estimated 6 to 12 million cases of head lice infestation among children aged 3 to 11 years. Head lice are most common among preschool children attending child care, elementary school children and members of households where children have lice.

Sklice is for external use only and should be used only on the scalp and dry hair in accordance with label directions, the FDA noted. The lotion is not approved for any other use.

Prescription-to-OTC switches are generally initiated by the manufacturer of a prescription drug, according to the FDA. Data must demonstrate the drug is safe and effective when used as directed in the labeling and the manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

Sklice will be marketed in the U.S. as a nonprescription drug and will no longer be available through a prescription, the FDA said. Consumers should read and follow the label for the nonprescription product. Patients who currently use the prescription version of the product should speak with their health care professional.