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

“Fast Track Designation represents an objective assessment by the FDA for the potential of NPI-001 tablets as a treatment for RP, a severe blinding disease,” said G. Michael Wall, PhD, senior vice president and chief scientific officer of Nacuity Pharmaceuticals, in a company press release. “We are committed to advancing NPI-001 to address this significant unmet medical need for patients suffering from RP.”

According to the company, 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, the company noted. In addition to Fast Track designation, Nacuity Pharmaceuticals said 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.