Product approved for prescription and over the counter indications
New York, N.Y. – Izun Pharmaceuticals Corporation (“Izun”, “Company”, izunpharma.com), a clinical stage company focused on developing high efficacy products based on pharmaceutical compounds derived from botanical sources announced today that the FDA has approved the Company’s 510(k) application for Curasite Wound Care Hydrogel. Curasite is a proprietary topical combination of three botanical extracts: Centella asiatica, Echinacea purpurea and Sambucus nigra in a hydrogel base. The prescription indications approved for use include the treatment of:
- Diabetic foot ulcers
- Leg ulcers, including venous stasis ulcers, arterial ulcers and ulcers of mixed etiology
- Full and partial thickness pressure ulcers
- 1st and 2nd degree partial thickness burns
The approved over-the-counter indications for use are:
- Minor abrasions
- Minor lacerations
- Minor cuts
- Minor scalds and burns
Mechanistically, in part, Curasite™ with its hydrogel base and botanical ingredients increases the moisture content within and around the wound by donating water, which makes the product effective in protecting the wound and in assisting the debridement and desloughing process in dry necrotic wounds, while maintaining a moist wound environment for optimal wound healing.
General product claims include:
- Positioned as first-line therapy
- Twice weekly dosing provides greater patient convenience and less wound disturbance
- Easy to use in home care setting.
Curasite™ was developed using Izun’s proprietary botanical technology, which has been studied in over 600 patients in an array of clinical trials in the United States and abroad. Curasite™ is the third product approved for marketing in the United States using the Company’s technology.
It is recommended to apply Curasite™ to a cleansed wound two to three times weekly. The product can be used as long as needed provided signs of healing occur within four weeks of first application without adverse effects.
Curasite™ was approved in part due to an 82 patient, double blind, active-controlled study that was conducted over 12 weeks duration. For the first four weeks, patients with chronic diabetic foot ulcers that were present, on average, for more than 6 months, were randomized in double blind fashion to either Curasite™ or hydrogel base alone. Wound healing was evidenced beginning in week 1 in both groups but plateaued in the hydrogel base control group, whereas the Curasite™-treated group exhibited highly significant and continual progressive improvement throughout this portion of the study, reaching an average of over 50% wound closure (p < 0.0001) at 4 weeks compared to baseline.
After this 4 week double blind portion of the study, patients from both groups were then treated with Curasite™ open-label for an additional eight weeks. Patients initially administered hydrogel base who then crossed over to Curasite™ treatment began to incrementally heal their wounds. Patients in the Curasite™ group who then continued on Curasite™ for a total of 12 weeks also saw progressive improvement. For both groups the average reduction in wound size was nearly 90% at twelve weeks. More than half of patients in the follow-up portion of the study reached complete wound closure at twelve weeks of therapy.
Jack V. Talley, Chief Executive Officer of Izun commented: “We are delighted that the FDA approved our application. Diabetic foot ulcers and many of the other cited indications are poorly served by current treatment modalities. The consequences of unhealed wounds in these patient populations can be tragic. Izun is evaluating marketing partners to assist in a timely commercialization of Curasite in the United States as soon as possible”.
Izun is applying its patented proprietary, botanically-based pharmaceutical technology in several areas of unmet medical need. These include a completed single blind study to treat atrophic vaginitis. Additionally, a study for the prevention of oral mucositis in solid tumor patients receiving chemotherapy and radiation has completed enrollment and results are expected in the second quarter of 2017.