Vallon Pharmaceuticals Inc. (NASDAQ: VLON) has announced topline results from the pivotal SEAL study assessing ADAIR, a novel abuse-deterrent formula for immediate release dextroamphetamine for attention deficit hyperactivity disorder treatment.
Vallon to seeking a formal meeting with FDA
CEO and President David Baker said, “I would like to extend our sincere appreciation to our clinical team and CRO partners for their hard work and dedication to execute the study, and to all of the study participants. While we are disappointed by the primary endpoint results, many of the topline findings are encouraging and provide valuable insight. As we gain additional insight from further analysis of all study endpoints, we will determine next steps for the development program, including plans to request a formal meeting with the FDA in the coming months and the potential for an additional study.”
The SEAL study is then the company’s vital intranasal human abuse liability trial assessing the pharmacokinetics, pharmacodynamics, safety, and tolerability of snorting professional lab-manipulated ADAIR 30 mg compared to crushed d-amphetamine sulfate and placebo in recreational users. A pharmacist prepared ADAIR for snorting through a multi-step technique created by a professional lab and accepted by the FDA. The SEAL trial enrolled 55 participants, of which 53 finalized the study, and 52 were included in the final analysis. The trial entailed a four-way crossover design to assess professionally manipulate intranasal ADAIR 30 mg, crushed dextroamphetamine, oral ADAIR 30 mg, and placebo.
Initial study failed to meet the primary endpoint.
The trial didn’t meet the primary endpoint of Emax Drug Liking. However, interestingly ADAIR attained similar to what was seen in an earlier proof-of-concept study did not score as high as anticipated and as observed in the study before.
Chief Medical Officer Timothy Whitaker said, “Although the lower mean results for ADAIR on the primary endpoint did not reach statistical significance, the results of the pharmacodynamics secondary endpoints, Overall Drug Liking and Take Drug Again, were all statistically significant and encouraging. Beyond these topline results, additional calculation and analysis of other endpoints with our CRO partner will begin shortly including the pharmacokinetic results and results of other exploratory endpoints.”