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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Born, Stephanie Gauvin, David V. Mukherjee, Suman Briscoe, Richard |
| Description | Author Affiliation: Born S ( Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: stephanie_born@merck.com.); Gauvin DV ( MPI Research, Inc., Mattawan, MI, USA.); Mukherjee S ( Merck & Co., Inc., Kenilworth, NJ, USA.); Briscoe R ( Merck & Co., Inc., Kenilworth, NJ, USA.) |
| Abstract | Suvorexant (Belsomra ) is a dual orexin receptor antagonist approved for the treatment of insomnia. Because of its pharmacology within the central nervous system, intended therapeutic indication, and first-in-class status, an assessment of suvorexant abuse liability potential was required prior to marketing approval. The nonclinical abuse liability potential studies for suvorexant included: 1) rat drug-dependence model to assess physical dependence following abrupt cessation; 2) rat drug-discrimination model to examine the potential similarity of the interoceptive or subjective effects of suvorexant to those elicited by zolpidem and morphine; 3) self-administration model to assess the relative reinforcing efficacy of suvorexant in rhesus monkeys conditioned to self-administer methohexital. No significant signs of spontaneous drug withdrawal or 'discontinuation syndrome' were observed in rats following abrupt discontinuation of suvorexant. Suvorexant did not elicit complete cross-generalization to either a zolpidem or morphine training/reference stimuli in rats, and suvorexant was devoid of behavioral evidence of positive reinforcing efficacy in monkeys. These nonclinical findings suggested that suvorexant will have low abuse potential in humans. In the final regulatory risk assessment, suvorexant was placed into Schedule IV, likely due to its first-in-class status, its sedative properties, and the outcome of the clinical abuse potential assessment. |
| File Format | HTM / HTML |
| ISSN | 02732300 |
| Journal | Regulatory Toxicology and Pharmacology |
| Volume Number | 86 |
| e-ISSN | 10960295 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2017-03-06 |
| Publisher Place | Netherlands |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Pharmacology |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Toxicology |
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