Shares in NicOx shot up 19% to a six- month high of 11.20 euros on November 24, after the firm released results from the last of three late-stage trials confirming that its lead product, naproxcinod, is safe, effective and does not raise blood pressure.
The French drug developer plans to submit the New Drug Application on the osteoarthritis painkiller to US regulators in mid-2009 and says it is still in talks with potential marketing partners.
The pivotal Phase III trial in patients with OA of the hip showed a highly statistically-significant result (p<0.001) on all three co-primary efficacy endpoints. Naproxcinod 750mg also showed the same gastrointestinal adverse event rate and blood pressure profile as placebo. The predicted blockbuster is the most advanced compound in the novel cyclooxygenase-inhibiting nitric oxide donator class.
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