Cardiol Therapeutics Announces FDA Investigational New Drug Application (IND) Authorization for Multicenter Phase II Open-Label Pilot Study of CardiolRx(TM) for Recurrent Pericarditis
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화요일, 5월 17, 2022
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Recurrent pericarditis is an orphan disease in the United States, thereby making CardiolRx eligible for orphan drug status under the FDA's Orphan Drug Designation program.
Key Points:
- Recurrent pericarditis is an orphan disease in the United States, thereby making CardiolRx eligible for orphan drug status under the FDA's Orphan Drug Designation program.
- Cardiol's study is expected to enroll 25 patients at major clinical centers specializing in pericarditis in the United States.
- The NRS is a validated clinical tool used across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
- Cardiol believes there is a similar opportunity to develop its oral CardiolRx formulation as an orphan drug for the treatment of recurrent pericarditis.