Why Vallon Pharma Shares Are Staring At 52-Week Low Today

  • Vallon Pharmaceuticals Inc VLON shares are plunging after releasing topline results from its Phase 1 SEAL study evaluating ADAIR, an abuse-deterrent formulation of immediate-release (IR) dextroamphetamine for attention deficit hyperactivity disorder (ADHD).
  • The study did not meet its primary endpoint, Emax Drug Liking. ADAIR scored similarly to what was observed in an earlier proof-of-concept study. 
  • However, reference dextroamphetamine did not score as high as expected, thus driving the lack of statistical significance.
  • All pharmacodynamic secondary endpoints of the study were met with ADAIR scoring significantly lower than reference dextroamphetamine on Overall Drug Liking assessed at 12 hours and 24 hours post-dosing. 
  • The post-hoc analysis demonstrated that Mean Drug Liking for intranasal ADAIR was lower than reference dextroamphetamine at each time point from 15 minutes through 24 hours after dosing, reaching statistical significance for each time point from 15 minutes through 6 hours post-dosing.
  • Additionally, the data showed that manipulated ADAIR was more irritating and less comfortable to snort than crushed dextroamphetamine. However, formal statistical analysis of the SRAII scale has not yet been completed.
  • Last month, the USPTO issued a patent covering the use of Vallon's ADAIR for cognitive impairment (COVID brain fog) associated with COVID-19.
  • Price Action: VLON shares are down 75.9% at $1.79 during the premarket session on the last check Monday.
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