Safety profile of tasimelteon, a melatonin MT1and MT2receptor agonist: pooled safety analyses from six clinical studies

Sep 23, 2015Expert opinion on drug safety

Safety of tasimelteon, a drug acting on melatonin receptors, based on combined results from six clinical studies

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Abstract

A total of 258.64 patient years of exposure to tasimelteon was assessed in individuals with Non-24 and insomnia.

Tasimelteon is the first approved treatment specifically for Non-24-hour Sleep-Wake Disorder.
In clinical studies, common side effects included headache, diarrhea, dry mouth, and dizziness.
Discontinuation rates due to adverse events were similar between tasimelteon and placebo groups.
Safety assessments showed no significant differences in ECGs, vital signs, or suicidality between treatment groups.
Long-term use of tasimelteon was found to be safe and well-tolerated in the studied populations.

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INTRODUCTION: Tasimelteon, a novel circadian regulator, is the first product for the treatment of Non-24-hour Sleep-Wake Disorder (Non-24) approved by either the FDA or the European Medicines Agency (EMA). Tasimelteon is a potent and specific melatonin (MT1 and MT2) receptor agonist with 2 - 4 times greater affinity for the MT2 receptor.

METHODS: Safety was assessed in two controlled and two open-label studies in blind individuals with Non-24 and in two controlled studies of primary insomnia. Periodic assessments included collection of adverse events (AEs), laboratory testing, electrocardiograms (ECGs), vital sign monitoring, physical examinations and assessment for the potential for suicide. One study included additional assessments for endocrine function.

RESULTS: A total of 184 blind individuals with Non-24 received tasimelteon nightly with a median exposure > 1 year. In placebo-controlled studies, 387 patients with insomnia and 42 patients with Non-24 received tasimelteon nightly for 4 - 26 weeks. The total patient years exposure for the six studies assessed here is 258.64 patient years. Discontinuations due to AEs were similar across treatment groups. Overall in the clinical studies described here, AEs attributable to tasimelteon treatment were headache, diarrhea, dry mouth, alanine aminotransferase increased, somnolence, dizziness and nightmare/abnormal dreams. There were no clinically significant differences in treatment group with ECGs, vital signs, withdrawal, endocrine function and suicidality assessments.

CONCLUSION: Long-term tasimelteon administration was safe and well-tolerated. This is supported by placebo-controlled data in both Non-24 and insomnia patients.

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Safety profile of tasimelteon, a melatonin MT1and MT2receptor agonist: pooled safety analyses from six clinical studies

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