Averitas Pharma, Inc., announced its supplemental New Drug Application (sNDA) for a new drug to treat neuropathic pain has been accepted by the U.S. Food and Drug Administration (FDA).
The drug, named QUTENZA would be to treat neuropathic pain associated with diabetic peripheral neuropathy. It is already approved in the U.S. for the management of neuropathic pain associated with postherpetic neuralgia.
How would it work?
QUTENZA delivers high concentrations of the TRPV1 agonist, capsaicin through the skin, directly to the damaged nerves that are the source of neuropathic pain.
The spontaneous activity of the TRPV1 sensitive nerves decreases and consequently also the neuropathic pain intensity.
If approved, QUTENZA would be the first topical treatment with a TRPV1 agonist indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
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 patients.
According to the drug company, 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.
The FDA has set a goal date for review and approval under the Prescription Drug User Fee Act (PDUFA) of July 19, 2020.
Averitas Pharma, Inc.
- Averitas Pharma, Inc. (2019, July 19). Averitas Pharma Announces FDA Acceptance of sNDA Filing for QUTENZA® (capsaicin) 8% Patch for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy. Business Wire. Retrieved December 18, 2019, from https://prnmedia.prnewswire.com/news-releases/averitas-pharma-announces-fda-acceptance-of-snda-filing-for-qutenza-capsaicin-8-patch-for-the-treatment-of-neuropathic-pain-associated-with-diabetic-peripheral-neuropathy-300976908.html