OnDosis has selected Adare Pharma Solutions to provide development and manufacturing services for Imfocy, its lead U.S. program for attention-deficit/hyperactivity disorder. The proposed product combines extended-release oral pellets containing mixed amphetamine salts with OnDosis’ Dosage Manager device, which is designed to allow individualized dosing.
Under the collaboration, Adare will support development of the oral formulation and provide manufacturing capabilities for the U.S. market. The company works on oral solid medicines, including controlled-substance formulations.
OnDosis Chief Executive Martin Olovsson said the partnership is intended to establish commercial-scale manufacturing capacity in the United States. Adare will support the program as it approaches pivotal bioequivalence studies and a planned application to the U.S. Food and Drug Administration through the 505(b)(2) pathway.
Bioequivalence studies compare how a drug product performs in the body with a reference treatment. The planned studies will be a step in the development of OnDosis’ extended-release product before its proposed regulatory submission.
OnDosis, based in Sweden, develops drug-device combinations for oral medicines. Its Dosage Manager platform is intended to dispense doses tailored to individual patients rather than relying solely on fixed-dose products. For Imfocy, the device would deliver pellets containing mixed amphetamine salts, a class of medicines used to treat ADHD.
Adare said it also plans to make the dosing approach available to other clients developing medicines for different conditions. Chief Executive Tom Sellig said the company would apply its drug-delivery and manufacturing capabilities to the OnDosis program and potential future projects.
The collaboration centers on development, regulatory preparation and U.S. manufacturing of the investigational ADHD product.