Arakoda Malaria Prophylaxis Confirmed Safe and Tolerable in Long-Term Analysis
Weekly Arakoda for malaria prevention was found safe and tolerable for healthy adults who travel internationally.
A long-term safety study of the anti-malarial Arakoda found it to be clinically safe and well tolerated after 12 months of weekly administration. Arakoda is indicated for the prophylaxis of malaria in patients 18 years and older.
Arakoda (tafenoquine) addresses the unmet need for a safe medication that prevents malaria among international travelers. Due to its long terminal half-life of ~16 days, Arakoda is advantageous for individuals in want of less frequent dosing.
Tafenoquine was discovered by the Walter Reed Army Institute of Research and approved for malaria prophylaxis in 2018. Arakoda has been marketed in the US by 60 Degrees Pharmaceuticals since 20219.
There was no increased risk of psychiatric or significant ophthalmologic adverse events for tafenoquine as compared to placebo. According to Geoffrey Dow, CEO of 60 Degrees Pharmaceuticals, “Healthcare providers who prescribe tafenoquine to prevent malaria in their patients can take an added measure of comfort that this therapy is safe and well tolerated."
The most common adverse reactions of tafenoquine, with incidence greater than 1%, were headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams and anxiety.
The study, Long-Term Safety Study of Tafenoquine, was a randomized, prospective, double-blind, placebo-controlled study. It enrolled 601 adult volunteers, who were randomized to receive either tafenoquine or placebo once a week for 12 months, after a 3-day loading dose.
During the study, ophthalmologic, psychiatric, neurologic, and general safety endpoints were analyzed. The study included only healthy volunteers with no comorbidities.
60 Degrees Pharmaceuticals (60P) works to develop new medicines to treat and prevent tropical diseases. 60P’s mission is supported with funding from the US Department of Defense.