AT3022 utilizes Altea’s proprietary PassPort transdermal system, developed to deliver water-soluble small molecules, proteins, carbohydrates and oligonucleotides across the skin.
AT3022 is designed to provide a safer and more efficacious alternative to the currently marketed fentanyl patches that can only deliver the highly lipid-soluble base form of fentanyl.
In July 2005, the FDA issued a public health advisory in response to safety-related events in patients using marketed fentanyl patches to manage their pain. Primary safety concerns with marketed fentanyl patches include the formation of depots of fentanyl base in the skin leading to slow elimination after patch removal, and long times to reach steady state, both of which combine to make accurate dose titration lengthy and difficult.
Further, the presence of a large amount of fentanyl base in the patch after removal can lead to drug abuse, and patch leakage or application of a heat source can lead to dose-dumping that may have life-threatening consequences.
The use of the PassPort transdermal system to deliver the highly water-soluble fentanyl salt is intended to mitigate each of these concerns.
“The current safety of opioids for treatment of severe pain is a pressing issue for clinicians and regulatory agencies,” stated Dr Eric Tomlinson, president and CEO of Altea Therapeutics. “AT3022 incorporates layers of potential deterrents against product abuse, misuse, and diversion and provides rapid and sustained delivery of a highly effective opioid, fentanyl citrate.”