The US Food and Drug Administration (FDA) on Friday released draft guidance for sponsors developing stimulant drugs for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric and adult patients.
FDA explains how ADHD is a common neurobehavioral disorder with onset in childhood. Stimulant drugs (e.g., methylphenidate, amphetamine) are the most commonly prescribed medications for treatment of ADHD, the agency said.
The 7-page draft guidance, which is specifically for methylphenidate and amphetamine products, explains how in certain circumstances, additional clinical trials may not be necessary if a company is using the 505(b)(2) application pathway. The guidance also explains several issues that need to be considered when developing methylphenidate and amphetamine products via this pathway.
“FDA believes it is reasonable to rely on safety information from a listed drug to develop new methylphenidate or amphetamine product via the 505(b)(2) application pathway and, in certain cases, it may be reasonable to rely on the efficacy information. For instance, if a 505(b)(2) applicant can establish a bridge to the relied-upon listed drug by demonstrating either bioequivalence or comparative bioavailability of the proposed drug product with the listed drug, additional clinical trials may not be necessary to support approval of the 505(b)(2) application,” the draft says…