Nutriband's AVERSA Fentanyl Patch and collaboration with Kindeva

Kindeva has already approved the Fentanyl patch. It was approved in November 2016. 

This news is about an abuse-resistant Fentanyl patch. 

The patches often contain a large surplus of the therapeutic agent to ensure that a therapeutically effective dose is delivered to the patient over the intended period. As a result, used patches can hold a significant amount of drug even after the prescribed use. Additionally, many of these drugs are highly potent and susceptible to intentional abuse or accidental misuse, which can lead to severe adverse reactions if ingested by children or animals.

Nutriband Inc., in collaboration with Kindeva, has reached a major milestone with the successful completion of commercial manufacturing and scale-up for its AVERSA Fentanyl, an abuse-deterrent transdermal patch. According to analysts, a new $15 price target for Nutriband underscores the company's progress toward starting clinical supplies production and submitting an Investigational New Drug (IND) application for a Phase 1 trial.

Nutriband Inc. holds a granted patent in the US, patent number US 12,318,492. It protects its AVERSA™ transdermal abuse-deterrent technology.

If company’s NDA  ie 505 (b) (2) application is approved by FDA this patent could be listed in the Orange Book. 

The invention provides an abuse deterrent or misuse deterrent transdermal patch system comprising a patch backing layer, wherein one or more aversive agents is incorporated into or irreversibly adhered onto the distal side of the patch backing layer, and wherein the one or more aversive agents exhibits a biphasic or sustained release profile when immersed in a dissolution medium.

The use of aversive agents could be a key invention in AVERSA™ transdermal abuse-deterrent technology. An aversive agent is any substance that causes a strong, temporary, non-lethal negative reaction in an animal, including humans, when exposed to it. Such aversive agents include bittering agents, pungent agents, and emetic agents.

Some examples of aversive agents include denatonium benzoate, denatonium saccharide, sucrose octaacetate, quercetin, capsaicin, resiniferatoxin, quassin, brucine, piperine, allyl isothiocyanate, alum, copper sulfate, and emetine.

AVERSA Fentanyl could reach peak annual US sales of $80 million to $200 million. While initially targeting the US market, the unmet medical need for effective pain management is a worldwide issue, and the company plans to establish AVERSA as a global solution by strategically addressing all major medical markets.  

The AVERSA program follows the 505(b)(2) regulatory pathway and requires only a single Phase 1 study, which aims to demonstrate reduced appeal to recreational drug users—an approach the analyst considers low risk. Full-year sales are expected to begin in FY2027, with the NDA submission planned between late 2025 and early 2026.

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