OnDosis, Adare Partnered on ADHD Precision Dosing
The collaboration unites a device platform with manufacturing services for a U.S. ADHD drug launch.
Updated on Oct. 1, 2026 in Healthcare
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OnDosis and Adare Pharma Solutions have entered a strategic collaboration to develop an extended-release oral pellet product for ADHD treatment. The partnership leverages OnDosis' Dosage Manager platform to prepare for a 505(b)(2) regulatory submission in the U.S.
Why it matters
The deal signals an integration of hardware-enabled dosing into the 505(b)(2) regulatory pathway for pharmaceutical manufacturers. By combining precision dosing devices with contract manufacturing, the firms aim to streamline the clinical development process for ADHD therapeutics.
The partnership focuses on a single lead ADHD candidate, Imfocy, utilizing mixed amphetamine salts in an extended-release format. The scope of this agreement covers the development phase for the U.S. market, with Adare planning to expand this technology to other clients.
The players
OnDosis
A Swedish-based company that develops drug-device combinations designed for the precision dosing of oral solid medicines.
Adare Pharma Solutions
A contract development and manufacturing organization (CDMO) that provides end-to-end oral solid dosage form manufacturing services.
The details
Adare Pharma Solutions will serve as the contract development and manufacturing organization (CDMO) to support the end-to-end production of OnDosis' oral solid dosage form. The workflow integrates OnDosis' proprietary Dosage Manager platform, designed for individualized precision dosing of solid medicines. This technical alignment is specifically calibrated to support the data requirements for a 505(b)(2) filing, a path often used to accelerate regulatory approval for modified versions of existing drugs.
Timeline
October 1, 2026: OnDosis and Adare announced the strategic collaboration.
Market Landscape
This collaboration aligns with the industry-wide focus on the FDA 505(b)(2) regulatory pathway, which permits the use of existing clinical data to accelerate the approval of modified therapeutics. It reflects a broader trend of integrating specialized hardware platforms into pharmaceutical contract manufacturing to meet complex dosing requirements.
Operators in the pharmaceutical and medtech sectors should monitor the outcome of the upcoming bioequivalence studies as a benchmark for device-drug integration costs. Evaluate whether incorporating precision hardware into your R&D pipeline aligns with your specific regulatory and manufacturing margins.
The takeaway
This deal underscores the growing reliance on CDMO partnerships to navigate the complexities of combined drug-device regulatory submissions. Monitor the 505(b)(2) submission status for Imfocy as an indicator of how regulatory bodies respond to integrated precision dosing platforms.
Further reading
For more on industry shifts in clinical development, visit our Healthcare section.
Source note: This article includes information reported by News-Medical.
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