Oral warts are severe, chronic, debilitating and disfiguring with no existing satisfactory treatment.
Therapy consisting of surgery, freezing or cautery is only partially effective.
The oral formulation is administered as a lozenge which is allowed to dissolve slowly in the mouth. The orphan designation process is the mechanism by which sponsors of drugs and biologics for rare diseases qualify for the tax credit and marketing exclusivity incentives of the Orphan Drug Act. The Office of Orphan Products Development also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials to support the approval of drugs for rare diseases. The US patient population with HIV and persistent oral warts has been estimated at less than 5,000. Amarillo Biosciences has been granted Orphan Drug status previously for orally-administered interferon alpha for the treatment of Behcet's disease and a meeting with FDA, regarding Behcet's disease, has been requested.