Date: 2017-02-06
Type of information: Filing of an IND
phase: 1
Announcement: filing of an IND
Company: Alcobra (Israel)
Product: ADAIR (Abuse-Deterrent, Amphetamine Immediate-Release)
Action
mechanism: Alcobra's Abuse-Deterrent Amphetamine Immediate-Release (ADAIR) product candidate is a proprietary, abuse-deterrent oral formulation of immediate-release (short-acting) dextroamphetamine that is currently under development for the treatment of ADHD. ADAIR is being specifically designed to limit abuse by snorting or injecting. The ADAIR formulation was developed in close collaboration with Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions.
Disease: Attention Deficit Hyperactivity Disorder (ADHD)
Therapeutic area: CNS diseases - Mental diseases - Neurological diseases
Country: USA
Trial details:
Latest
news: * On February 6, 2017, Alcobra announced that it has reached a regulatory milestone in the development of ADAIR (Abuse-Deterrent, Amphetamine Immediate-Release), a novel product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). The company recently held a pre-IND meeting with the FDA to discuss the details of the proposed 505(b)(2) development program. The FDA provided guidance on the necessary steps towards an NDA, which is expected to be submitted before the end of 2018. Alcobra expects its existing financial resources to support the development program of ADAIR to NDA filing.
