An estimated 47,000 cases of babesiosis (red blood cell infections caused by deer tick bites) occur each year in the United States and their occurrence is increasing. Babesiosis is endemic in the Unidos. Se states and an estimated 10% of patients with Lyme disease are coinfected with babesiosis. Post-exposure prophylaxis after a tick bite is an identified indication to prevent Lyme disease, and it is very likely that a drug with demonstrated efficacy for this indication of babesiosis will also be used in conjunction with Lyme prophylaxis.
60P plans to continue its marketing efforts similar to ARAKODA (tafenoquine), an antimalarial drug indicated for malaria prophylaxis in patients 18 years of age and older and approved through the FDA® in 2018. In the second quarter of 2023, ARAKODA sales increased to 150% to the same quarter of 2022.
“Obviously, there remains an unmet need to provide safe and effective treatment to the low-risk COVID-19 patient population and we have seen that tafenoquine holds promise in addressing this need,” said Geoff Dow, M. D. , CEO of 60 Degrees Pharmaceuticals. To determine whether it is possible to move forward with modifying ACLR8-LR to meet FDA requirements, we will continue existing efforts such as expanding our malaria business and submitting an IND for a more detailed study of how tafenoquine might be effective in malaria control. Babesiosis. “
About ARAKODA® (Tafenoquine)
Tafenoquine was discovered through the Walter Reed Institute of Military Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially introduced in 2019 and are lately distributed through pharmaceutical wholesaler networks in each of the respective countries. country. They can be purchased at retail pharmacies as a prescription-only malaria prevention medication.
According to the Centers for Disease Control and Prevention, tafenoquine’s long terminal half-life, which is about 16 days, would possibly offer potential benefits in terms of less common management for malaria prophylaxis. ARAKODA is not suitable for everyone, neither for patients nor for prescribers. Review the vital protection data below.
Neither ARAKODA nor tafenoquine have been approved by the FDA for the treatment or prevention of babesiosis.
ARAKODA® (Tafenoquine) Important Safety Information
ARAKODA is an antimalarial drug indicated for the prophylaxis of malaria in people over 18 years of age.
ARAKODA will not be administered:
Warnings and precautions
Adverse reactions: The maximum non-unusual adverse reactions (incidence greater than or equivalent to 1%) were headache, dizziness, back pain, diarrhoea, nausea, vomiting, elevated alanine aminotransferase (ALT) levels, dizziness, insomnia, depression, dreams and anxiety.
Drug interactions Avoid co-administration with biological cation transporter 2 (OCT2) substrates or multidrug-toxin extrusion transporters (MATE).
Use in populations
Breast-feeding: Advise women not to breastfeed a baby with G6PD deficiency or a baby whose G6PD status is unknown 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. Full prescribing data for ARAKODA can be obtained here.
About 60 Degrees Pharmaceuticals, Inc. 60 Degrees Pharmaceuticals, Inc. , founded in 2010, specializes in the progression and commercialization of new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60P effectively obtained FDA approval for its flagship product, ARAKODA® (tafenoquine), for malaria prevention in 2018. 60P also collaborates with leading study organizations in the United States, Australia, and Singapore. The 60P project was supported through in-kind investments from the U. S. Department of Defense. U. S. and institutional staff investors, adding Knight Therapeutics Inc. , a specialized Pan-American pharmaceutical corporation founded in Canada. 60P is headquartered in Washington D. C. and a majority-owned subsidiary in Australia. Learn more about www. 60 Degreespharma. com.
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Media Contact: Sheila A. BurkeSheilaBurke-consultant@60 Degreespharma. com (484) 667-6330
Investor Contact: Patrick Gaynespatrickgaynes@60 Degreespharma. com (310) 989-5666
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