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.
The deadline for responses to the Army’s request for information on Tafenoquine is 20 May 2019.
