Naproxcinod
Treatment for: Duchenne Muscular Dystrophy
Nicox Receives Orphan Drug Designation from FDA for Naproxcinod in Duchenne Muscular Dystrophy
Sophia Antipolis, France - 19 March 2015 -- Nicox S.A. (Euronext Paris: COX) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for naproxcinod for the treatment of Duchenne Muscular Dystrophy (DMD). ODD is a status granted to drugs or biological products that treat rare diseases or conditions. The designation qualifies the sponsor of the drug for various development incentives, including a period of US marketing exclusivity upon marketing approval for the designated indication, potential tax credits and the waiver of certain fees1.
Naproxcinod is a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate currently under evaluation by an undisclosed financial partner for potential clinical development in DMD2. Nicox has granted the undisclosed partner the exclusive right, should the results of the evaluation be satisfactory to the partner, to invest at the end of the evaluation period in naproxcinod and next generation nitric oxide (NO)-donors outside ophthalmology through an independent structure.
DMD is the most common and serious form of muscular dystrophy, a group of inherited diseases that cause muscle weakness and muscle loss. Naproxcinod already showed promising preclinical results in models of muscular dystrophy3 and received a European Orphan Drug Designation for the treatment of DMD in October 2013.
References
- For more information, please visit the FDA website: http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm.
- See Nicox press release dated February 14, 2014.
- Long-term treatment with naproxcinod significantly improves skeletal and cardiac disease phenotype in the mdx mouse model of dystrophy, Uaesoontrachoon K, Quinn JL, Tatem KS, Van der Meulen JH, Yu Q, Phadke A, Miller BK, Gordish-Dressman H, Ongini E, Miglietta D, Nagaraju K. Hum Mol Genet. 2014, 15; 23(12):3239-49.
Posted: March 2015
Related articles
- Nicox to re-focus Naproxcinod on Duchenne Muscular Dystrophy - February 14, 2014
- NicOx Provides Update on U.S. Regulatory Status of Naproxcinod - April 4, 2012
- FDA provides Complete Response Letter to NicOx's New Drug Application for naproxcinod - July 22, 2010
- NicOx provides update on FDA Advisory Committee Meeting for naproxcinod - May 13, 2010
- NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12 - March 8, 2010
- NicOx announces FDA accepts naproxcinod NDA for filing - November 18, 2009
- NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA - September 25, 2009
Naproxcinod FDA Approval History
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