Vallon Pharmaceuticals’ abuse-resistant Adderall has flunked a key test. ADAIR performed no better than the reference formulation of the stimulant dextroamphetamine on a measure of abuse liability, causing the trial to miss its primary endpoint and Vallon’s share price to collapse.
The formulation embeds the active ingredient in a semi-solid, waxy paste inside a gelatin capsule. The waxy paste is designed to be extremely difficult to reduce into particles, thereby preventing people from breaking up and snorting the medication. However, the technology failed to yield the hoped-for result in a clinical trial.
Investigators enrolled 55 recreational stimulant users to take intranasal ADAIR prepared by a pharmacist, crushed intranasal dextroamphetamine, oral ADAIR and placebo in a four-way crossover design. ADAIR did no better statistically on a measure of abuse potential—peak effect for Drug Liking—than reference dextroamphetamine, causing the clinical trial to miss its primary endpoint.
Vallon noted a “trend in favor of ADAIR”, with the p-value clocking in at 0.16, but the most encouraging signs that the drug isn’t a complete bust came from a clutch of secondary endpoints that looked at other measures.
“Although the lower mean results for ADAIR on the primary endpoint did not reach statistical significance, the results of the pharmacodynamic secondary endpoints, Overall Drug Liking and Take Drug Again, were all statistically significant and encouraging,” Timothy Whitaker, M.D., chief medical officer at Vallon, said in a statement.
Overall Drug Liking and Willingness to Take Drug Again were significantly lower in the ADAIR arms at 12 and 24 hours post-dosing. Vallon also has preliminary evidence that ADAIR is more irritating and less comfortable to snort than crushed dextroamphetamine, although it is yet to complete statistical analysis of the results. Full analysis of pharmacokinetic results and exploratory endpoints is still to come, too.
Investors have already seen enough to deliver their verdicts. Shares in Vallon fell almost 70% after the market opened, bringing the price of the stock down to around $2.30.