FDA grants Nicox orphan drug designation for naproxcinod in Duchenne muscular dystrophy

19 March 2015
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French ophthalmic specialist Nicox (Euronext Paris: COX) has been granted orphan drug designation by the US Food and Drug Administration for naproxcinod in Duchenne muscular dystrophy.

The drug is a cyclooxygenase-inhibiting nitric oxide-donating anti-inflammatory candidate currently under evaluation for an undisclosed financial partner for development in Duchenne muscular dystrophy. Nicox has granted the partner the exclusive right to invest at the end of the evaluation period in naproxcinod and nitric oxide-donors outside ophthalmology through an independent structure.

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 fees.

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