OnDosis and Adare Pharma Solutions have entered into a strategic collaboration aimed at advancing OnDosis’ lead U.S. drug-development program for attention-deficit/hyperactivity disorder (ADHD). Under the agreement, Adare will provide CDMO services for OnDosis’ investigational extended-release oral pellet formulation containing mixed amphetamine salts. The product is being developed for delivery through OnDosis’ Dosage Manager platform, a drug-device system designed to provide more individualized dosing of oral solid medicines. The partnership combines OnDosis’ precision-dosing technology with Adare’s capabilities in oral solid-dose development and manufacturing. Adare also brings experience working with controlled-substance formulations, an important consideration for an amphetamine-based ADHD product.

OnDosis says the collaboration is intended to establish commercial-scale manufacturing capabilities in the United States as the company advances its lead program toward pivotal bioequivalence studies and a planned 505(b)(2) regulatory submission. The lead product, Imfocy, is designed to deliver mixed amphetamine salts in an extended-release pellet formulation through the Dosage Manager platform. According to OnDosis, the approach is intended to provide greater flexibility in dosing for patients receiving ADHD treatment.

“We are truly excited to take this important step and establish a commercial-scale manufacturing capability on US soil through this strategic partnership with Adare,” says Martin Olovsson, CEO and co-founder of OnDosis. He says Adare’s development and manufacturing capabilities will support the program as it moves toward pivotal bioequivalence work and the subsequent regulatory submission.

The agreement is also intended to create a pathway for Adare to apply the underlying precision-dosing approach to other pharmaceutical programs. Adare plans to make the technology available to additional clients developing treatments for different indications. The companies view the drug-device approach as potentially applicable to medicines where dosing flexibility could address varying patient requirements.

“This program is a very innovative delivery solution that’s very much needed to serve diverse patient dosing requirements,” says Tom Sellig, CEO of Adare Pharma Solutions. He adds that Adare intends to apply its drug-delivery and manufacturing expertise both to OnDosis’ program and to other development programs where greater dosing precision and flexibility could be beneficial.

For OnDosis, the collaboration represents a manufacturing milestone as it works toward the next stage of development for Imfocy in the U.S. The company is pursuing a 505(b)(2) pathway, a regulatory route that can allow sponsors to rely in part on previously established information about an approved drug while providing additional data supporting the proposed product.

The immediate development objectives include completion of pivotal bioequivalence studies and preparation for the planned U.S. regulatory submission. OnDosis is developing its Dosage Manager platform as a drug-device combination intended to enable individualized delivery of oral solid medicines. The company’s partnership with Adare expands the manufacturing infrastructure supporting its lead ADHD program while potentially creating opportunities to apply the platform across additional therapeutic areas. The companies did not disclose financial terms of the collaboration.