Transdermal pharmaceutical product manufacturer Nutriband and CDMO Kindeva have completed commercial manufacturing process scale-up for Aversa Fentanyl.
Aversa Fentanyl, Nutriband's lead product, is designed to prevent the abuse, misuse and accidental exposure of drugs with abuse potential — including opioids and stimulants.
Combining Nutriband's Averse abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, Aversa Fentanyl will be manufactured at Kindeva's US transdermal manufacturing facility.
The companies are currently planning to embark on the next step of the development process, which will involve the manufacture of clinical supplies, as well as the filing of an IND application with the FDA.
“Completing the commercial manufacturing scale-up is an important step towards development of a commercially viable product and eventual NDA filing," noted Nutriband's CEO, Gareth Sheridan.
"This achievement demonstrates the compatibility of the Aversa abuse deterrent platform technology with established transdermal patch manufacturing processes. Aversa Fentanyl has the potential to be the first abuse deterrent pain patch on the market,” he added.
Nutriband's Aversa technology can be used to incorporate aversive agents into transdermal patches, which can improve the safety profile of transdermal drugs susceptible to abuse such as fentanyl.
This means that patients who need these drugs can access them with a decreased risk of dependency.
According to Nutriband, Aversa Fentanyl has the potential to reach peak annual US sales of $80–200m.
The solution will first be introduced to the US market, with the brand looking for further opportunities globally later down the line.
