Results of a long-term safety study of ARAKODA® (tafenoquine) in healthy volunteers have been published in the peer-reviewed journal Travel Medicine and Infectious Disease, according to 60 Degrees Pharmaceuticals, LLC (60P), a pharmaceutical company focused on developing new medicines for tropical diseases.
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WASHINGTON, Nov. 19, 2021 /PRNewswire/ -- Results of a long-term safety study of ARAKODA® (tafenoquine) in healthy volunteers have been published in the peer-reviewed journal Travel Medicine and Infectious Disease, according to 60 Degrees Pharmaceuticals, LLC (60P), a pharmaceutical company focused on developing new medicines for tropical diseases. ARAKODA is an anti-malarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. The study, Long-Term Safety Study of Tafenoquine, was a randomized, prospective, double-blind, placebo-controlled study in which ophthalmologic, psychiatric and neurologic and general safety endpoints were evaluated. A total of 601 adult volunteers were randomized [~1:1] to receive tafenoquine or placebo weekly for 12 months following a three-day loading dose. Participants were followed for up to six months following completion of dosing to monitor adverse events. The study found ARAKODA (tafenoquine) administered for 12 months to be generally safe and well tolerated. When administered according to prescribing information, there was no difference observed between ARAKODA (tafenoquine) and placebo in terms of the incidence of serious ophthalmologic safety events (the primary endpoint of the study), and no elevated risk of psychiatric events over 12 months of dosing was observed. "We are pleased to see, as expected based on previous peer-reviewed research, that ARAKODA (tafenoquine), when used as directed, does not appear to increase the risk of psychiatric or clinically significant ophthalmologic adverse events," said Geoffrey Dow, Chief Executive Officer of 60P. "As such, healthcare providers who prescribe ARAKODA to prevent malaria in their patients can take an added measure of comfort that this therapy is safe and well tolerated." About ARAKODA® According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. At approved doses in healthy individuals, tafenoquine does not prolong cardiac repolarization [QTC interval]. ARAKODA is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. ARAKODA (tafenoquine) Important Safety Information ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. Contraindications ARAKODA should not be administered to:
Warnings and Precautions
Adverse Reactions Drug Interactions Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. Use in Specific Populations Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ARAKODA full prescribing information is here. About 60 Degrees Pharmaceuticals 60 Degrees Pharmaceuticals (60P), founded in 2010, focuses on developing new medicines for treatment and prevention of tropical diseases, including malaria and dengue. 60P's mission is supported through in-kind funding from the U.S. Department of Defense. The company also collaborates with prominent research organizations in the U.S. and Australia. 60P is headquartered in Washington D.C., with a subsidiary in Australia. Further information is available on the company's website, www.60degreespharma.com. Media Contact
SOURCE 60P |
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