The U.S. Army Medical Research Acquisition Activity (USAMRAA) located at FT. Detrick, MD, has issued a solicitation outlining plans to conduct User Acceptance Testing for the malaria prophylactic drug (Tafenoquine) brand name Arakoda.
The announcement (W81XWH-19-R-0052) supports sourcing of one commercial lot of ~120,000 tablets (7,500 packages) of Tafenoquine brand name Arakoda immediately, with options to procure up to 3 orders of 3,750 packages each.
The Tafenoquine shall have the following essential characteristics:
- FDA approved Tafenoquine succinate tablets for oral use, indicated for the prevention of malaria in adults for up to 6 months of continuous dosing.
- Each tablet contains 100 mg of tafenoquine free base for oral use only.
- The dosing regimen for tafenoquine consists of a loading dose of 2 x 100 mg tablets once daily for 3 days before travel to a malarious area, followed by weekly 2 x 100 mg maintenance doses while in the malarious area, followed by one dose of 2 x 100 mg in the week following exit from the malarious area.
- Tafenoquine tablets can be taken with or without food.
- Tafenoquine 100 mg tablets packed in blister packs of 8 tablets per blister card. A package of Tafenoquine contains 16 tablets (two blister cards).
- Tafenoquine tablets can be stored at 20°C to 25°C (68°F to 77°F); with excursions permitted to 15-30°C (59-86°F).
The stated goal of the initial operational testing is to gain information regarding user compliance of a weekly dosing schedule versus a daily schedule; the suitability of packaging; its ability to be used in multiple operational environments; and a single dose post deployment instead of the current standard of care (SOC) 14-day treatment course.
The operational testing will look at the drug’s performance attributes and usability. User feedback will be used to evaluate U.S. Service Members’ preference for a weekly medication, positive or negative side effects compared to the current standard of care prophylactic malaria medications, and general comments on ease of use of the packaging.