Panel believes that more safety data is needed.
NicOx’ share price plummeted 43% on the announcement that FDA’s advisory panels had voted 16-1 against approval of the firm’s osteoarthritis candidate, naproxcinod. There was one abstention in the vote. The Advisory Panel’s verdict was that it did not have sufficient evidence to support approval of naproxcinod and would need data from additional safety studies.
FDA now has until July 24 to make a final decision on whether to sanction the drug. NicOx filed its marketing authorization application to the European regulatory authorities in December 2009.
Naproxcinod is a cyclooxygenase-inhibiting nitric oxide donator (CINOD) compound, developed as an anti-inflammatory for treating the signs and symptoms of osteoarthritis. The drug’s clinical development program included 35 studies involving more than 6,500 subjects. The NDA filing was based on data from three Phase III trials, all of which met their co-primary efficacy endpoints, the firm points out.
NicOx’ nitric oxide-donating R&D platform is being exploited to develop a pipeline of NMEs for the potential treatment of inflammatory, cardiometabolic, and ophthalmological diseases. In November 2009, NicOx reported positive results from a first-in-man Phase Ib trial evaluating its NO-donating HMG-CoA reductase inhibitor, NCX 6560, which is in development in house as a potential treatment to help reduce the risk of major adverse cardiac events in coronary heart disease patients. The placebo-controlled study, which compared the effects of treatment using either NCX 6560 or Lipitor® (atorvastatin) met both its primary and secondary objectives.
In March 2010, the firm granted Bausch and Lomb an exclusive, worldwide license to develop and commercialize the Phase II-stage NO-donating prostaglandin F2-alpha analog, NCX 116, for the treatment of glaucoma and ocular hypertension. Under the terms of that deal NicOx received $10 million up front and could earn another $169.5 million in milestones.
NicOx is also working in partnership with Merck & Co. to develop NO-donating antihypertensives and with Ferrer Grupo for the development of NO-donating products for skin disorders including atopic dermatitis, psoriasis, and seborrheic dermatitis.