Food and Drug Administration perspective: Advancing product development for non‐healing chronic wounds

Abstract

The US Food and Drug Administration (FDA) understands that innovative product development is essential to addressing the unmet medical need of non-healing chronic wounds. Barriers to product development for non-healing chronic wounds may involve but are not limited to a dearth of biological models, challenges in drug delivery, challenges in clinical trial execution, and limited commercial viability. This perspective article discusses FDA's renewed focus on non-healing chronic wounds and outlines efforts to address identified barriers to product development for nonhealing chronic wounds. In collaboration with key wound healing stakeholders including academia, professional associations, patient groups, reimbursement organizations and industry, FDA intends to help advance product development for non-healing chronic wounds for the ultimate betterment of patients.

Neutralizing Staphylococcus aureus PAMPs that Trigger Cytokine Release from THP-1 Monocytes

“…Instead, they become trapped in a state of pathological inflammation, persistent infections, and necrosis and exhibit resistance to the normal repair process. Because of the ongoing inflammation in chronic wounds, the clinical management for these wounds continues to present a challenge and current technologies do not have a specific focus on the treatment of chronic nonhealing wounds . The FDA acknowledges that there is a lack of available innovative products for treating nonhealing chronic wounds and emphasizes that it is crucial to overcome barriers to product development in this area .…”

“…Because of the ongoing inflammation in chronic wounds, the clinical management for these wounds continues to present a challenge 40 and current technologies do not have a specific focus on the treatment of chronic nonhealing wounds. 41 The FDA acknowledges that there is a lack of available innovative products for treating nonhealing chronic wounds and emphasizes that it is crucial to overcome barriers to product development in this area. 41 To date, the FDA has only approved one product called becaplermin gel, along with two moderately effective cell-based therapies, Dermagraft and Apligraf (developed by Organogenesis, Canton, MA), for the treatment of chronic nonhealing wounds.…”

“… 41 The FDA acknowledges that there is a lack of available innovative products for treating nonhealing chronic wounds and emphasizes that it is crucial to overcome barriers to product development in this area. 41 To date, the FDA has only approved one product called becaplermin gel, along with two moderately effective cell-based therapies, Dermagraft and Apligraf (developed by Organogenesis, Canton, MA), for the treatment of chronic nonhealing wounds. Furthermore, there is currently no small-molecule drug approved by the FDA specifically for treating nonhealing chronic wounds.…”

Biomaterials Based on Organic Polymers and Layered Double Hydroxides Nanocomposites: Drug Delivery and Tissue Engineering

“…No therapy with small-molecule drugs has been approved up to now [ 174 ]. Some challenges to the development of products for non-healing chronic wounds include scarcity of biological models (chronic wounds are uncommon in animals and difficult to simulate) and challenges in clinical trial execution and in drug delivery (release kinetics modulation) [ 266 ].…”

Breakthrough treatments for accelerated wound healing

“…However, the pathologic responses to chronic wounds and scarring are complex, and discrepancies between the immune system and inflammatory response to injury between animal models and humans may affect translation to clinical practice ( 115 – 118 ). Chronic wounds are uncommon in animals and challenging to stimulate ( 119 ). FDA guidance suggests that there are no adequate animal models for chronic wounds, and multiple models should be considered to assess wound healing products ( 110 , 120 ).…”