FDA Grants Orphan Drug Status to Nutra Pharma's Multiple Sclerosis Treatment

Nutra Pharma (OTC:NPHC) has announced that it has received Orphan Drug designation from the U.S. Food and Drug Administration for the company’s treatment for juvenile Multiple Sclerosis, RPI-78M. The biotechnology company is otherwise known for its marketing of Nyloxin® and Pet Pain-Away as over-the-counter pain management treatments.
According to the press release:

The designation of RPI-78M as an Orphan Drug provides Nutra Pharma with a 7-year period of market exclusivity in the U.S. once the drug is approved. Additional benefits over conventional drug applications include: tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, plus assistance from the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees which could be in excess of $2.5 million. The granting of Orphan Drug Designation allows the Company to move forward with their preparation of an Investigative New Drug Application and proposal of clinical trials. The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. According to the FDA, the Orphan Drug program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. Evaluate Ltd., in its 2014 EvaluatePharma Orphan Drug Report, estimated that orphan drug sales will constitute 19% of the total share of prescription drug sales by 2020, totalling $176bn.

Click here to read the full press release from Nutra Pharma.