ATLANTA, Sept. 14, 2022 (GLOBE NEWSWIRE) -- Veritas Collaborative, a specialty healthcare system for the treatment of eating disorders, and Project HEAL, the only major direct service nonprofit in the U.S. focused on equitable healthcare access for people with eating disorders, announced a new partnership designed to increase access to eating disorder treatment for individuals who are currently underrepresented in eating disorder treatment - particularly those who are low-income, underinsured, or marginalized.
AACHEN, Germany and MORRISTOWN, N.J., March 30, 2021 /PRNewswire/ -- Grünenthal announced today that its U.S. subsidiary, Averitas Pharma, Inc. will conduct a Phase III trial to study the efficacy, safety and tolerability of QUTENZA (capsaicin) 8% topical system in post-surgical neuropathic pain (PSNP) with the goal to expand the current U.S. product label. The randomised, double-blind trial AV001 will include between 400 and 500 patients who have been suffering from moderate to severe PSNP for at least six months, and aims to demonstrate a significant reduction in the average pain intensity after 12 weeks and 42 weeks compared to the baseline. In addition, the trial will assess other outcomes like progressive response over time with repeated application, reduction of the treatment area over several applications, and Quality of Life outcomes such as sleep interference, physical activity, anxiety and depression. First patients are expected to be enrolled in the third quarter of 2021 with trial completion expected in 2024.
Averitas Pharma, the New Jersey, USA-based subsidiary of Germany’s Grünenthal, has won a new approval…
AACHEN, Germany and MORRISTOWN, N.J., July 21, 2020 /PRNewswire/ -- Grünenthal announced today that its U.S. subsidiary Averitas Pharma, Inc. received U.S. Food and Drug Administration (FDA) approval for QUTENZA® (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults.[2] QUTENZA® is a topical, non-systemic, non-opioid pain treatment delivered in the form of a patch and is the first and only treatment of its kind to deliver prescription strength capsaicin directly into the skin.
MORRISTOWN, New Jersey, Dec. 18, 2019 /PRNewswire/ -- Averitas Pharma, Inc., a subsidiary of GRT US Holding, Inc. and member of the Grünenthal Group, announced today that 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.