Company intends to initiate confirmatory study in calendar H1, incorporating feedback received from FDA; 510(k) filing expected in calendar Q3, as planned
FRAMINGHAM, Mass., May 08, 2018 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB:ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, today announced that it will initiate the previously disclosed study designed to address the Food and Drug Administration’s (FDA or "the agency") comments on Arch’s previous 510(k) submission for its AC5TM Topical Gel. The agency has provided feedback via the pre-submission process and has indicated that the proposed study design is acceptable to support the Company’s future marketing application. At present, the Company believes that there are no other material items to address with the agency.
Terrence Norchi, MD, President & Chief Executive Officer of Arch, commented, “We view the agency’s comments as important, addressable, and straightforward. While this study on intact skin to test for sensitization still needs to be completed, the overall body of evidence to date, including results from a required animal test for sensitization, are favorable. Further, we believe that the testing will address the agency’s questions and be helpful in future regulatory submissions.”
Arch intends to initiate the study in the next few weeks incorporating FDA’s comments and, assuming supportive study findings, expects to file the 510(k) notification in the third calendar quarter of 2018. That 510(k) notification would contain both the information previously reviewed by the FDA and the additional data discussed with the agency.
As previously disclosed, Arch voluntarily withdrew the 510(k) notification after receiving comments from the FDA late in the review process for which a complete response could not be provided within the time remaining in the agency’s statutorily-mandated review period. The agency requested further evidence that the product does not cause sensitization in humans. While the Company respectfully disagreed that further evidence should have been necessary, after seeking feedback from the FDA, Arch decided it most expeditious to provide further documentation and perform a non-invasive human study designed with leading experts in the field. The Company requested agency feedback on the study design via the pre-submission process.
Dr. Norchi added, “We are very pleased with the input that the agency provided, which we deliberately sought before starting the trial. We still expect the trial to cost approximately $100,000 and take about three months.”
Arch remains focused on manufacturing scale-up, clinical regulatory strategy, developing commercial partnerships, advancing intellectual property and expanding its pipeline of products.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.
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Source: Arch Therapeutics, Inc.