July 21st, 2015 written by: Daniela Semedo, PhD
Nutra Pharma, a US-based biotechnology a company specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases, recently announced that it has filed an application with the US Food and Drug Administration (FDA) for orphan drug status for its investigational drug RPI-78M as a treatment for pediatric multiple sclerosis (MS).
The company markets Nyloxin and Pet Pain-Away in the over-the-counter (OTC) pain management market, and also develops treatments for multiple sclerosis (MS), HIV, adrenomyeloneuropathy (AMN) and general pain.
If the orphan drug designation is granted to RPI-78M, it would provide the company with a seven-year period of market exclusivity in the US upon receiving FDA approval.
The FDA Orphan Drug Designation program provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
In the US, it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods intended to encourage the development of drugs, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees, which can offer savings of us to $2.5 million.
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