[FDA News Release, October 27, 2020] – The U.S. Food and Drug Administration has approved Ivermectin lotion 0.5% for nonprescription use for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice (Ivermectin lotion, 0.5%) was initially approved for this indication in 2012 as a prescription drug. The OTC approval was granted to makers of Sklice through a process called a prescription (Rx)-to-OTC switch.
“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” said Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”
Sklice is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.
Pediculosis capitis or head lice are caused by Pediculus humanus var. capitis (P. h. capitis). The arthropods are transmitted from human to human via direct contact – sharing of combs, brushes, towels. Pruritus is a common complaint associated with the infestation. The nits are usually seen at the base of the hairs.
Head lice are most common among children, individuals with long hair, homeless people and refugees. School children who share school caps, hairbrushes and combs, pillowcases are particularly vulnerable.
In Nigeria, Permethrin 1% cream rinse is the currently approved treatment for P. capitis (NSTG, 2016).
Sources:
- FDA News Release, October 27, 2020
- FDA: Treating and Preventing Head Lice
- SKLICE® Prescribing Information
- Nigeria’s Standard Treatment Guidelines (NSTG), 2016 ed.