(RxWiki News) The US Food and Drug Administration (FDA) has approved a treatment for Chagas disease.
This treatment is called Lampit (nifurtimox). The FDA approved it for children up to age 18 who weigh at least 2.5 kg (a little more than 5.5 lbs).
Chagas disease is caused by the parasite Trypanosoma cruzi, which is transmitted to humans by triatomine bugs via their feces.
Also referred to as American trypanosomiasis, Chagas disease is commonly found in rural areas of Latin America; however, it can be found in other places.
In fact, Chagas affects an estimated 300,000 people in the US.
And according to the Centers for Disease Control and Prevention (CDC), it is estimated that Chagas affects as many as 8 million people in Central America, Mexico and South America. But most of these people do not know they are infected.
Chagas disease can be treated and cured. However, if left untreated, the infection is lifelong and can be life-threatening.
Available in tablet form, Lampit is designed so it can be split easily along scored lines using your hands. Furthermore, the tablet can be mixed in water and made into a slurry, which can help those who may have problems swallowing whole or half tablets.
This medication is dosed by weight and is to be given three times a day with food.
The accelerated approval of Lampit was based on data from a prospective, double-blind, phase 3 trial conducted in Argentina, Bolivia and Columbia.
Common side effects of Lampit included nausea and vomiting, stomach pain, headache, reduced appetite, fever and rash.
This new approval was granted to Bayer.