ARAKODA® (Tafenoquine) Clinical safety, tolerance confirmed in a long-term safety study; Results published in Tropical Medicine and Infectious Disease

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WASHINGTON, November 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 diseases, according to 60 Degrees Pharmaceuticals, LLC (60P), a pharmaceutical company focused on the development of new drugs for tropical diseases.

ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients 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, neurologic and general safety parameters were evaluated. A total of 601 adult volunteers were randomized [~1:1] receive tafenoquine or placebo once a week for 12 months after a three-day loading dose. Participants were followed for up to six months after the end of treatment to watch for adverse events.

The study found ARAKODA (tafenoquine) given for 12 months to be generally safe and well tolerated. When administered according to the prescribing information, no difference has been 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 was observed during the 12 months of ‘administration.

“We are delighted 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 Geoffroy Dow, managing director of 60P. “Thus, healthcare providers who prescribe ARAKODA to prevent malaria in their patients can take an extra measure of comfort as this therapy is safe and well tolerated. “

About ARAKODA®
Tafenoquine was discovered by the Walter Reed Army Institute of Research and this study was funded by the US Army Medical and Material Development Activity. [USAMMDA]. Tafenoquine was approved for the prophylaxis of malaria in 2018 in United States like ARAKODA (tafenoquine) and Australia like KODATEF®. Both were launched commercially in 2019 and are currently distributed through pharmaceutical wholesale networks in each respective country. They are available in retail pharmacies as a prescription malaria prevention drug only.

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is around 16 days, may offer potential benefits in less frequent dosing for malaria prophylaxis. At approved doses in healthy individuals, tafenoquine does not prolong cardiac repolarization [QTC interval].

ARAKODA is not 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 18 years of age and older.

Contraindications

ARAKODA should not be administered to:

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status
  • Breastfeeding by a nursing woman when the child has a G6PD deficiency or if the G6PD status is unknown
  • Patients with a history of psychotic disorders or current psychotic symptoms
  • Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines or any component of ARAKODA

Warnings and precautions

  • Hemolytic anemia: The G6PD test must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
  • G6PD deficiency during pregnancy or lactation: ARAKODA may harm the fetus when given to a pregnant woman whose fetus is deficient in G6PD. ARAKODA is not recommended during pregnancy. An infant deficient in G6PD may be at risk for hemolytic anemia due to exposure to ARAKODA through breast milk. Check the infant’s G6PD status before starting to breastfeed.
  • Methemoglobinemia: Asymptomatic increases in blood methemoglobin have been observed. Initiate appropriate treatment if signs or symptoms of methemoglobinemia appear.
  • Psychiatric effects: Serious psychotic side effects have been observed in patients with a history of psychosis or schizophrenia at doses other than the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thoughts or behavior) occur, consider stopping treatment. ARAKODA therapy and evaluation by a mental health professional as soon as possible.
  • Hypersensitivity reactions: Serious hypersensitivity reactions have been observed with the administration of ARAKODA. If hypersensitivity reactions occur, institute appropriate treatment.
  • Delayed side effects: Due to the long half-life of ARAKODA, (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia and hypersensitivity reactions may be delayed in onset and / or duration.

Side effects
The most common side effects (incidence 1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams and anxiety.

Drugs interactions

Avoid co-administration with drugs that are organic cation transporter-2 (OCT2) substrates or multiple drug and toxin extrusion transporters (MATE).

Use in specific populations

Breast-feeding: Women should not breast-feed an infant with G6PD deficiency or an 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 the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ARAKODA full prescribing information is here.

About 60 pharmaceutical degrees

60 Degrees Pharmaceuticals (60P), founded in 2010, focuses on the development of new drugs for the treatment and prevention of tropical diseases, including malaria and dengue. 60P’s mission is supported by in-kind funding from the US Department of Defense. The company also collaborates with leading research organizations in the United States and Australia. 60P is headquartered at Washington DC, with a subsidiary at Australia. Further information is available on the company’s website, www.60degreespharma.com.

Media contact
Geoffroy Dow, CEO of 60P
202-327-5422
[email protected]

SOURCE 60P

Related links

http://www.60degreespharma.com


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