La FDA aprueba nuevo tratamiento para los Piojos
Escrito por Dr. Hector Yee
Lunes, 05 de Marzo de 2012 19:06
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Marzo 5, 2012. Actualmente en México, solo existe la invermectina en presentación oral ( IVEXTERM®).

FDA Approves New Lotion for Head Lice Treatment

February 9, 2012 — Sanofi Pasteur US has announced that it received US Food and Drug Administration (FDA) approval to market its ivermectin-formulated lotion as a treatment for head lice in children aged 6 months and older and in adults. Branded as Sklice Lotion, the treatment is applied for 10 minutes and eliminates the need for nit combing.

Head lice infect an estimated 6 to 12 million children aged 3 to 11 years annually, according to the US Centers for Disease Control and Prevention. An infection can cause loss of school days for children and work days for parents as people try to prevent the spread of lice through head-to-head contact.

"Through a unique mode of action, Sklice Lotion resolves most head lice infestations in one application and is very well-tolerated," said Kenneth P. Guito, general manager of Sanofi-Topaz, in a news release. Topaz Pharmaceuticals, which Sanofi acquired last October, developed the lotion.

A spokesperson for Sanofi said the product would be available in retail stores in several months by prescription only.

The FDA based its approval on the results of 2 randomized phase 3 clinical trials, according to the prescribing information. Primary endpoints in the trial were the proportion of lice-free patients 2 and 14 days after treatment. In the first trial, 76.1% (54/71) of the Sklice-treated patients were lice-free without any nit combing after 2 weeks compared with 16.2% (12/74) in the placebo group. The results were similar in the second trial, at 71.4% (50/70) and 18.9% (14/74), respectively.

Adverse events were assessed in 379 patients, aged 6 months and older. Less than 1% of patients experienced adverse effects, including conjunctivitis, eye irritation, dandruff, dry skin, or skin-burning sensation, according to the prescribing information.

Sklice is based on the antiparasitic agent ivermectin, which has been used since 1987 against river blindness (worm infection) and other parasitic problems.

Because its safety has not been established in babies younger than 6 months, Sklice is not recommended for that age group. In addition, no adequate studies have been conducted with pregnant women using Sklice, and Sanofi recommends that it be used during pregnancy "only if the potential benefit justifies the potential risk to the fetus."

Sanofi also recommends that Sklice only be used for children under direct supervision of adults, because of the risk for possible ingestion.




Última actualización el Miércoles, 07 de Marzo de 2012 00:48