FDA approves Sanofi’s ivermectin head lice treatment for over-the-counter use

pharmafile | October 29, 2020 | News story | Sales and Marketing  

The FDA has approved Sanofi’s Sklice (ivermectin) for over-the-counter use. 

Sklice is a single-use lotion that includes ivermectin 0.5% as the active ingredient. It had been previously approved for prescription for use in patients six months or older in 2012. It was previously prescription only, and only advised to be used on the scalp and dry hair. These prescription switches are initiated by the drug’s manufacturer. 

This new approval will see the lotion being marketed in the US as a non-prescription drug, but people who use prescription versions of this product are advised to talk to their healthcare provider.

Dr Theresa Michele, Acting Director of the Office of Non-prescription Drugs in the FDA’s Center for Drug Evaluation and Research, commented: “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. 

“Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

In the US it is estimated that between six and 12 million cases of head lice infestation occur each year in children 3 to 11 years of age according to the CDC, and most common among pre-school children.

The lotion only contains a small dosage of ivermectin, but the drug is one being investigated in treating multiple conditions. Ivermectin was developed in the 1970s as a new class of drug to treat parasitic infections. It was initially used in veterinary medicine before being used to treat onchocerciasis and lymphatic filariasis; 3.7 billion doses are estimated to have been given since its approval. It has also been studied as a potential treatment for influenza and HIV.

Back in June, a US clinical trial of the drug ivermectin found that it reduced the mortality rate of COVID-19 patients by 40%. This study was published in medRxiv and was led by Dr Jean-Jacques Rajter, a physician at Broward Health Medical Center. The study assessed 280 coronavirus patients over the age of 18, with 173 being treated with the drug and 107 having standard care for the virus. The study found that overall mortality in those who took the treatment was 15% compared to those who did not take it, who had a 25% mortality rate. This would equate to a 40% drop overall.

The most notable result in the study showed that the drug had a significant effect on the very high-risk group of COVID-19 patients suffering from severe pulmonary disease. Of the patients who did not receive ivermectin, 81% died, while only 39% died when receiving the treatment, improving their survival odds by just over 50%. 

Conor Kavanagh

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