NeurogesX wins European positive opinion for neuropathic pain drug

NeurogesX, a biopharmaceutical company, has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

The Committee for Medicinal Products for Human Use’s (CHMP) positive opinion recommending approval of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults was made in reliance on NeurogesX’s commitment to conduct certain post-marketing studies.

These post-marketing commitments, which are often required by the CHMP as a condition of an approval recommendation, may include an open-label safety study of Qutenza in on-label indications, as well as a clinical safety and efficacy study in painful diabetic neuropathy.

The CHMP’s positive recommendation will be evaluated by the European Commission, and a decision on marketing authorization is expected in the next 60 to 90 days.

Anthony DiTonno, president and CEO of NeurogesX, said: The CHMP’s positive recommendation for approval of Qutenza in the EU provides significant validation for both Qutenza and NeurogesX. In preparation for a potentially positive final decision by the European Commission, we will be focused on finalizing a relationship with a commercial partner in Europe over the next few months.