Abuse Potential of Lasmiditan: A Phase 1 Randomized, Placebo- and Alprazolam-Controlled Crossover Study

Area of Science:

• Pharmacology
• Neuroscience
• Clinical Trials

Background:

• Lasmiditan is a selective serotonin 5-hydroxytryptamine receptor 1F agonist for acute migraine treatment.
• Assessing the abuse potential of novel therapeutics is crucial for public health and regulatory approval.

Purpose of the Study:

• To evaluate the abuse potential of lasmiditan in recreational polydrug users.
• To compare the drug-liking effects and safety profile of lasmiditan against placebo and alprazolam.

Main Methods:

• A phase 1, randomized, placebo- and positive-controlled crossover study was conducted.
• Participants received placebo, alprazolam 2 mg, or lasmiditan at 100, 200, or 400 mg.
• The primary endpoint was the maximal effect score (Emax) of the Drug-Liking Visual Analog Scale.

Main Results:

• Lasmiditan did not produce similar drug-liking scores to placebo across all tested doses.
• Drug-liking scores for lasmiditan 400 mg were not significantly different from alprazolam, but lower doses were significantly different.
• Treatment-emergent adverse events were mild and increased with lasmiditan dose.

Conclusions:

• The subjective drug-liking effects and safety profile suggest lasmiditan has a low potential for abuse.
• These findings support the development of lasmiditan as a potentially safe and effective migraine therapy.