AzoneTS™

Technology Overview

Echo is marshalling its AzoneTS transdermal reformulation technology to develop a pipeline of novel, proprietary reformulations of FDA-approved pharmaceutical products.

Compared to oral formulations, Echo’s AzoneTS transdermal reformulation technology can:

  • Provide once-daily to once-weekly delivery systems with steady drug action;   
  • Eliminate first-pass metabolism;   
  • Introduce less drug into the body to achieve therapeutic blood levels;
  • Increase patient compliance and convenience;
  • Reduce food and systemic drug interactions and associated side effects; and
  • Reduce certain forms of drug abuse. 

Echo believes its AzoneTS transdermal drug delivery platform has the potential to expand the number of drugs – in many more therapeutic categories – that can be delivered transdermally.

Properties

AzoneTS is an effective, nontoxic, penetration enhancer that is known to increase lipid membrane fluidity in the stratum corneum, thereby decreasing the diffusion resistance to topically applied therapeutics. AzoneTS is a chemical combination of pyrolidone and decylmethyl sulfoxide, both of which alone act as weak penetration enhancers.  Echo’s proprietary synergistic chemical combination enables AzoneTS to be a highly effective penetration enhancer at low concentration levels.  When combined with AzoneTS, the penetration of numerous FDA-approved drugs is improved from two to more than twenty fold. 

AzoneTS has been used as a penetration enhancer in 32 human clinical studies, 72 animal studies, and has proven to be a safe, nonirritating and clinically effective transdermal penetration enhancer.

4/48 Program™

Echo expects FDA approval of Durhalieve™ to be a watershed event in its effort to monetize its AzoneTS transdermal drug delivery platform, resulting in multiple AzoneTS product development and marketing partnership opportunities. Upon US market approval of Durhalieve™, Echo believes it will be positioned to offer its pharmaceutical partners a highly efficient and relatively low cost, advanced topical reformulation alternative for their FDA-approved oral and injectable specialty pharmaceutical products.

Echo’s AzoneTS 4/48 Program contemplates a $4 million, 48-month pipeline-to-NDA filing product development model in accordance with the FDA's Section 505(b)(2) guidelines, as executed by Echo and Cato Research.

Durhalieve™

Durhalieve™ is Echo’s lead  AzoneTS product candidate. Durhalieve is a topical AzoneTS reformulation of triamcinolone acetonide, a widely-used, medium potency corticosteroid approved by the FDA for treatment of corticosteroid-responsive dermatoses. Echo has filed a New Drug Application (NDA) with the FDA seeking market approval for Durhalieve for treatment of corticosteroid-responsive dermatoses. Echo is in discussions with the FDA regarding the manufacturing requirements remaining to secure FDA approval of Durhalieve.