References – Epoladerm

FDA Perspectives on Product Quality of Transdermal Drug Delivery Systems

Yellela S.R. Krishnaiah, PhD
US Food and Drug Administration

We believe Epoladerm’s proprietary spray film technology may lead to adhesion capabilities superior to those of transdermal patches (e.g. Epoladerm does not require any tape reinforcement), while maintaining comparable skin absorption capabilities to transdermal patches currently on the market.

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Adhesive properties: a critical issue in transdermal patch development

Francesco Cilurzo, Chiara G M Gennari, and Paola Minghetti
Expert Opinion on Drug Delivery

Specifically, because the Epoladerm technology does not require a patch to deliver the drug through the skin, we believe Epoladerm may have better adhesion to the skin and may have better accessibility, particularly around joints and other curved body surfaces.

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References – Probudur

Prolonged analgesia from Bupisome and Bupigel formulations: From design and fabrication to improved stability

Rivka Cohen, Hiba Kanaan, Gilbert J. Grant, Yechezkel Barenholz
Journal of Controlled Release

Based on data from early animal studies, Probudur has indicated post-operative control for up to 96 hours, which is 24 hours longer than the leading product on the market. If we are able to demonstrate a successful Phase III clinical trial, we believe Probudur may represent the first long acting local anesthetic with an opioid sparing label.

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References – NES100

Nanoparticulate peptide delivery exclusively to the brain produces tolerance free analgesia

Lisa Godfrey, Antonio Iannitelli, Natalie L. Garrettc, Julian Moger, Ian Imbert, Tamara King, Frank Porreca, Ramesh Soundararajan, Aikaterini Lalats, Andreas G. Schätzlein, Ijeoma F. Uchegbu
Journal of Controlled Release

There is pharmacological evidence of activity of MET enabled enkephalin in morphine-tolerant animals.

We believe the preliminary data from these early animal studies of NES100 support our belief that NES100 may have comparable preclinical activity to morphine in all animal pain models tested without the drug seeking, respiratory depression, and tolerance associated with opioids.

Currently, enkephalins are limited in their therapeutic potential by their pharmacokinetic profiles due to their inability to cross the blood-brain barrier to reach opioid receptors located in the central nervous system.

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Targeting Alternative Opioid Receptor Reduces Drug Side Effects

Sara E. Teller
Legal Reader

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Checklist for prescribing opioids for chronic pain

U.S. Department of Health and Human Services Centers Disease Control

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