Averitas Announces sNDA Filing for QUTENZA for Neuropathic Pain

Averitas Pharma announced the supplemental New Drug Application (sNDA) for QUTENZA for the treatment of neuropathic pain associated with diabetic peripheral neuropathy has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set a goal date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2020.

"This is a great step forward for Averitas and moves us closer towards our goal of getting QUTENZA FDA approved for this indication," said Gabriel Baertschi, CEO Grünenthal. "There are millions of patients with painful diabetic peripheral neuropathy who have so far struggled to find effective pain relief. Offering solutions for these patients' unmet needs is fully in line with our vision of working towards a world free of pain."

Diabetes is a group of diseases marked by high levels of blood glucose resulting from defects in insulin production, insulin action or both. According to the American Diabetes Association, in 2015, 30.3 million Americans, or 9.4% of the population, had diabetes. Diabetic neuropathies are the most prevalent chronic complications of diabetes. Long-standing peripheral neuropathic pain associated with peripheral neuropathy occurs in one of six diabetic subjects. Painful diabetic neuropathy is pain arising as a direct consequence of abnormalities of the somatosensory system in diabetic patients and predominantly affects the feet and legs. People with diabetes can develop nerve problems at any time, but risk rises with age, duration of diabetes, glucose control and presence of diabetic retinopathy.

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