Inhaled Pirfenidone Designated Orphan Drug for IPF

Genoa Pharmaceuticals announced that the FDA has granted Orphan Drug designation to pirfenidone (inhaled GP-101) for the treatment of idiopathic pulmonary fibrosis (IPF).

Currently Esbriet, an oral formulation of pirfenidone is under investigation for idiopathic pulmonary fibrosis in clinical trials. The oral formulation requires large doses to achieve efficacious lung levels.

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Genoa has reformulated pirfenidone for aerosol formation and inhaled, direct-lung delivery. This will allow for a smaller inhalation dose, possible elimination of safety and tolerability concerns, improved patient compliance, and an increased inhaled dose for superior IPF efficacy.

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