Sprinkles help the medicine go down
treatment to be very palatable.
The US Food and Drug Administration (FDA) has approved an innovative oral granule formulation of Novartis' Lamisil (terbinafine) which can be sprinkled on a child's food to treat ringworm of the scalp. The news follows an earlier request by the FDA to Novartis Pharmaceuticals, the US arm of the Swiss major, to develop a child-friendly form of Lamisil for tinea capitis, which most commonly affects children and is characterized by severe itching, dandruff and bald patches. Tinea capitis is a persistent and contagious fungal infection that usually does not respond to topical treatment, hence the need for a formulation palatable for children. Novartis Pharmaceuticals, who manufacturers Lamisil, has come up with the new dosage form as oral granules, which can be sprinkled on food and has been approved to be administered once a day for six weeks for use by children aged four and older. The actual dosage will be based on the weight of the child. "A parent's ability to sprinkle it on the food of a child, who may not like to take medicine, should go a long way to helping ensure the infection is properly treated and to limiting its spread," said Steven Galson, director of the FDA's Centre for Drug Evaluation and Research. The approval means that Novartis should benefit from the terms of the Best Pharmaceuticals Children's Act of 2002, which gives market exclusivity incentives to encourage drug manufacturers to conduct paediatric studies. It should also produce a nice boost to sales of Lamisil as Novartis' other formulations of the drug have gone off-patent in the USA. Novartis Pharmaceuticals was unavailable for comment at time of publishing.
