04.15.13
All AmericanPharmaceutical & Natural Foods Corporation (AAP), Billings, MT, was granted orphan drug status by the U.S. Food and Drug Administration for one of its patent-pending compounds. The new drug compound is designed for the treatment of Juvenile Rheumatoid Arthritis (JRA) joint and related tissue inflammation in the pediatric population.
“We’re gratified to be moving forward with a product that can bring relief to those suffering from JRA,” explains Jeff Golini, AAP executive scientist. “Achieving drug status from the FDA on a product—especially one that has zero side effects—is huge. Only a very small number of products submitted get this designation, so we’re extremely pleased.”
The orphan drug status designation clears the way for AAP to begin a second clinical study in the JRA population. “In this next phase of the research, which will follow FDA guidelines and be conducted in conjunction with a U.S. university, we’ll continue to explore the role of the new drug on joint and related tissue inflammation,” says Mr. Golini. The company plans to begin recruiting for the study soon.
“We’re gratified to be moving forward with a product that can bring relief to those suffering from JRA,” explains Jeff Golini, AAP executive scientist. “Achieving drug status from the FDA on a product—especially one that has zero side effects—is huge. Only a very small number of products submitted get this designation, so we’re extremely pleased.”
The orphan drug status designation clears the way for AAP to begin a second clinical study in the JRA population. “In this next phase of the research, which will follow FDA guidelines and be conducted in conjunction with a U.S. university, we’ll continue to explore the role of the new drug on joint and related tissue inflammation,” says Mr. Golini. The company plans to begin recruiting for the study soon.