In an effort to control the head lice infestations and drug resistance to the most commonly used head lice treatments, the US Food and Drug Administration (FDA) has issued a new guidance on developing topical drugs.
The new guidance submitted by the US FDA is meant to assist sponsors in the clinical development of drugs to treat head lice infestation.
Although there are many FDA approved prescription and non-prescription drugs, increased genetic resistance to commonly used lindane and pyrethroid treatments has called for development of additional drugs.
The FDA guidance suggests that the components of the investigational drug need to be defined and discussed with the Agency early on in the clinical development and during the different stages of the clinical trials to ensure safe and effective combinations for the intended target population.
The guidance also suggests that during the drug development, the trial population should be representative of the age, race and sex with head lice infestations. Geographical diversity should also be seen as a factor during these trials because some drugs vary by location.