Vallon’s ADHD med fizzles in clinical trials

March 23, 2022

Vallon Pharmaceuticals’ new ‘abuse-resistant’ ADHD med drug just got its report card and it’s not doing so well in school.

The Philadelphia-based company announced this week that its phase 3 trial for ADAIR failed to meet its primary endpoint.

ADAIR, or Abuse Deterrent Amphetamine Immediate Release, is an investigational new drug for the treatment of attention deficit hyperactivity disorder that was designed to deter users from crushing or snorting it. ADAIR is made from dextroamphetamine, the active ingredient used in other ADHD medications like Adderall. The study to evaluate the abuse liability, pharmacokinetics, safety, and tolerability of an abuse-deterrent d-amphetamine sulfate immediate-release formulation — or SEAL study — enrolled 55 participants and used data from 52 in the final analysis.

In tests of 'Drug Liking,' which can signal the potential for abuse of a drug, ADAIR finished with about the same results as reference dextroamphetamine and therefore did not meet statistical significance.

Despite not meeting its primary endpoints, ADAIR may have a chance for redemption. Some of the trial’s secondary endpoints, like 'Overall Drug Liking' and 'Take Drug Again' were statistically significant. Additionally, the drug demonstrated higher scores on each of the five parts of the Subject Rated Assessment of Intranasal Irritability, which suggests that ADAIR is more irritating to snort than the crushed reference drug.

Vallon is not giving up on ADAIR just yet. According to David Baker, CEO and president at the company, Vallon will talk to the U.S. FDA about plans for another study and next steps of development for the drug. “While we are disappointed by the primary endpoint results, many of the topline findings are encouraging and provide valuable insight,” Baker said.

Investors did not seem to echo Baker’s optimism with Vallon shares falling almost 70% after the announcement.