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10 Pharmacodynamics and Tolerability of Intranasally Administered Immediate-Release Amphetamine Sulfate Among Recreational Intranasal StimulantUsers

Published online by Cambridge University Press:  12 March 2019

Beatrice Setnik ,
Steve Caras ,
Terrilyn Sharpe  and
Stephen V. Faraone
Beatrice Setnik
Affiliation:
Vice President Scientific & Clinical Strategy, Early Phase, Syneos Health, Raleigh, NC, USA, and Department of Pharmacology and Toxicology, University of Toronto, Toronto, Canada
Steve Caras
Affiliation:
Vice President Clinical Development, Arbor Pharmaceuticals, LLC, Atlanta, GA, USA
Terrilyn Sharpe
Affiliation:
Director of Clinical Development, Arbor Pharmaceuticals, LLC, Atlanta, GA, USA
Stephen V. Faraone
Affiliation:
Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA
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Abstract

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Study Objective

Despite increased nonmedical use of ADHD prescription stimulants, there are limited data to inform selection of intranasal doses for abuse-potential evaluations. This study determined a dose of amphetamine sulfate that is tolerable and distinguishable from placebo on pharmacodynamic (PD) measures.

Methods

In this randomized, double-blind, placebo-controlled, dose-escalation study, healthy, nondependent, recreational stimulant users received a single intranasal dose of amphetamine sulfate (20, 30, or 40mg ; n=6 per group) or placebo (n=2 per group). PD and safety were assessed pre-dose and ≤24hours post-dose. Drug Liking was measured using a bipolar Visual Analogue Scale (VAS; 0–100). Dose selection criteria were complete dose insufflation (≥95%); demonstration of peak Drug Liking ≥75 points, and ≥15 points greater than placebo in ≥3 participants receiving active drug; and tolerability.

Results

Peak Drug Liking criteria were met in the 20-, 30-, and 40-mg groups by 2, 0, and 6 participants, respectively. Mean (SD) peak Drug Liking was 62 (13.0), 71 (17.8), and 93 (8.7) for amphetamine sulfate versus 54 (3.5), 76 (34.6), and 51 (0) for placebo in the 20-, 30-, and 40-mg groups, respectively. Thirteen participants experienced mild AEs (n=1, 4, 6, and 1 in 20-, 30-, 40-mg, and placebo groups, respectively), there were no serious or clinically significant AEs. The most common AE was nostril burning sensation (active drug, n=7). There were no instances of an incompletely insufflateddose.

Conclusion

A 40-mg intranasal dose produced distinguishable PD effects and was well tolerated. This dose has been selected for further abuse-potential evaluations.

Funding Acknowledgements: This study was funded by Arbor Pharmaceuticals, LLC.

Type
Abstracts
Information
CNS Spectrums , Volume 24 , Issue 1 , February 2019 , pp. 178
Copyright
© Cambridge University Press 2019