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Find Clinical Drug Pipeline Developments & Deals by Vallon Pharmaceuticals
The combined company will advance innovative pipeline of Natural Killer T modulating therapies for the treatment of inflammatory, fibrotic and autoimmune diseases, including GRI-0621, an inhibitor of type 1 NKT cells.
GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human NKT I cells. In in vitro studies and after 28 days dosing in the study GRI-0621-201, oral dosing of GRI-0621 has been shown to inhibit NKT I cells in patients.
Pharmacokinetic analysis showed that ADAIR (dextroamphetamine) intranasally demonstrated blunted pharmacokinetic profile compared to crushed and snorted dextroamphetamine including Cmax,Tmax, and AUC, especially during early time points up to 1, 2, and 4 hours after dosing.
ADAIR (dextroamphetamine), investigational new drug; a novel, patented formulation designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high".
Study did not meet primary endpoint of significant reduction in Emax Drug Liking for ADAIR (dextroamphetamine) vs reference dextroamphetamine, although a trend in favor of ADAIR was observed (p=0.16).
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.”
Results demonstrated that ADAIR had slower absorption and lower early exposure, and was less desirable to recreational drug abusers on key measures of abuse liability compared to commercially available dextroamphetamine.
The company's clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR. ADAIR has completed a Phase 1 pivotal bioequivalence study and a Phase 1 food effect study.