Nacuity Pharmaceuticals Granted FDA Fast Track Designation for NPI-001 Tablets for RP

Nacuity Pharmaceuticals announced that the FDA has granted Fast Track Designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary investigational therapy for the treatment of patients with retinitis pigmentosa (RP).

A drug may receive Fast Track designation if it is intended to treat a serious or life-threatening disease and demonstrates the potential to address an unmet medical need. A drug that receives Fast Track designation may benefit from more frequent interactions with the FDA throughout drug development. In addition, the Fast Track program allows for accelerated approval and priority review, if relevant criteria are met.

NPI-001 is a proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to target oxidative stress associated with diseases such as retinitis pigmentosa. According to Nacuity, preclinical studies indicate that NPI-001 boosts glutathione, the body’s most powerful endogenous antioxidant, to stop chemically aggressive oxygen molecules from damaging retinal cells. NPI-001 and related small molecules are potent antioxidants in several preclinical models that may lead to additional indications.

In addition to Fast Track Designation, NPI-001 has also been granted Orphan Drug Designation for RP which provides 7 years of FDA regulatory exclusivity for the product upon regulatory approval.