Vallon Pharmaceuticals Inc.

• Vallon Pharmaceuticals Inc.
• Health-Care

VLON

 We are a biopharmaceutical company primarily focused on the development and commercialization of proprietary biopharmaceutical products. We are developing prescription drugs for central nervous system (CNS) disorders and our current focus is the development of drugs with lower potential for abuse than currently available drugs. Our clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR, a proprietary, abuse-deterrent oral formulation of immediate-release (short-acting) dextroamphetamine for the treatment of attention-deficit/hyperactivity disorder, or ADHD, and narcolepsy. It is estimated that over 5 million Americans abuse prescription ADHD stimulants annually.

We intend to develop ADAIR for registration through the Section 505(b)(2) approval pathway, which obviates the need for large Phase 2 and Phase 3 efficacy and safety studies. See the section entitled “Business — Section 505(b)(2) Pathway” in this prospectus for more information regarding Section 505(b)(2) of the FDCA. Based on discussions held with FDA at a pre-IND meeting in January 2017, we believe the Section 505(b)(2) regulatory pathway is appropriate and will be acceptable to the FDA. We expect to request additional labeling based on studies that demonstrate the abuse-deterrent characteristics of the product as they relate to snorting, and possibly IV injection. While dextroamphetamine is approved by the FDA, our reformulation, ADAIR, is not. Prescription drug abuse is a large and growing problem in the United States and globally.

We filed our Investigational New Drug, or IND, application for ADAIR in June 2018 and the IND was cleared in July 2018. Subsequently, we successfully completed a Phase 1 pivotal bioequivalence study of ADAIR and a Phase 1 food effect study. The bioequivalence study enrolled 24 subjects and the food effect study enrolled 22 subjects. Both studies were conducted by Altasciences, a contract research organization, or CRO. 
 

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