The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Qutenza (capsaicin 8% patch; Averitas Pharma) for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Qutenza, a transient receptor potential vanilloid 1 receptor (TRPV1) channel agonist, is already indicated for the management of neuropathic pain associated with postherpetic neuralgia. In a phase 3 study evaluating the topical therapy in patients with diabetic peripheral neuropathy, treatment with capsaicin 8% patch resulted in modest pain and sleep quality improvements when compared with placebo.
“This is a great step forward for Averitas and moves us closer towards our goal of getting Qutenza FDA approved for this indication,” says Gabriel Baertschi, CEO Grünenthal. “There are millions of patients with painful diabetic peripheral neuropathy who have so far struggled to find effective pain relief.”
A Prescription Drug User Fee Act (PDUFA) target date of July 13, 2020 has been assigned to the application.
For more information visit averitaspharma.com.