SEP-363856

SEP-363856 (also known as SEP-856)[1] is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis.[2] The medication is being developed by the pharmaceutical companies Sunovion Pharmaceuticals and PsychoGenics Inc.[2]

SEP-363856
Names
IUPAC name
(7S)-4,7-Dihydro-N-methyl-5H-thieno[2,3-c]pyran-7-methanamine
Other names
SEP-856
Identifiers
3D model (JSmol)
ChemSpider
UNII
Properties
C9H13NOS
Molar mass 183.27 g·mol−1
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
Infobox references

Research has shown that SEP-363856 results in a greater reduction from baseline in the PANSS total score than placebo.[3] Treatment with SEP-363856, as compared with placebo, was also associated with an improvement in sleep quality.[3]

Adverse effects

The adverse effect profile of SEP-363856 differs from that of other antipsychotics because its mechanism of action does not involve antagonism of dopamine receptors in the brain, which is responsible for the drug-induced movement disorders (like akathisia) that may occur with those agents.[4] Some adverse events reported in preliminary clinical trials are somnolence, agitation, nausea, diarrhea, and dyspepsia.[4]

Pharmacology

Mechanism of action

The mechanism of action of SEP-363856 in the treatment of schizophrenia is unclear. However, it is thought to be an agonist at the trace amine-associated receptor 1 (TAAR1) and serotonin-1A receptor (5-HT1A) receptors.[5] This mechanism of action is unique among available antipsychotics, which generally antagonize dopamine receptors (especially dopamine receptor D2).[6][7]

Pharmacokinetics

The precise pharmacokinetic profile of SEP-363856 has not been reported, though the developer has suggested that the pharmacokinetic data supports once daily dosing.[5]

Research

As of 2018, Sunovion, the maker of another antipsychotic called lurasidone (Latuda), is conducting clinical trials on SEP-363856 in partnership with the preclinical research company PsychoGenics.[2][8][9] The U.S. Food and Drug Administration has granted SEP-363856 the breakthrough therapy designation.[5][10] In addition to schizophrenia, SEP-363856 is also being studied for the treatment of psychosis associated with Parkinson's disease.[10]

See also

References
  1. "SEP 363856 - AdisInsight". adisinsight.springer.com. Adis International Ltd. Retrieved 29 December 2018.
  2. Brooks, Megan. "New Psychotropic Drug for Schizophrenia Promising in Early Testing". Medscape. Reuters Health Information. Retrieved 29 December 2018.
  3. Koblan, Kenneth S.; Kent, Justine; Hopkins, Seth C.; Krystal, John H.; Cheng, Hailong; Goldman, Robert; Loebel, Antony (2020-04-16). "A Non–D2-Receptor-Binding Drug for the Treatment of Schizophrenia". New England Journal of Medicine. 382 (16): 1497–1506. doi:10.1056/NEJMoa1911772. ISSN 0028-4793. PMID 32294346.
  4. Brooks, Megan. "'Game Changer' for Schizophrenia on the Horizon?". Medscape. WebMD LLC. Retrieved 21 June 2019.
  5. "Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia". www.bloomberg.com. Bloomberg L.P. Retrieved 21 June 2019.
  6. Koblan, Kenneth; Hopkins, Seth; Justine, Kent; Hailong, Cheng; Goldman, Robert; Loebel, Antony (2019). "O12.5. Efficacy and Safety of Sep-363856, A Novel Psychotropic Agent with a Non-D2 Mechanism of Action, in the Treatment of Schizophrenia: A 4-Week, Randomized, Placebo-Controlled Trial". Schizophrenia Bulletin. 45: S199. doi:10.1093/schbul/sbz021.269.
  7. Dedic, Nina; Jones, Philip G.; Hopkins, Seth C.; Lew, Robert; Shao, Liming; Campbell, John E.; Spear, Kerry L.; Large, Thomas H.; Campbell, Una C.; Hanania, Taleen; Leahy, Emer; Koblan, Kenneth S. (2019). "SEP-363856, a Novel Psychotropic Agent with a Unique, Non-D2 Receptor Mechanism of Action". Journal of Pharmacology and Experimental Therapeutics. 371 (1): 1–14. doi:10.1124/jpet.119.260281. PMID 31371483.
  8. "Sunovion – Our Therapies". www.sunovion.us. Sumitomo Dainippon Pharma Co., Ltd. Retrieved 29 December 2018.
  9. "About Us". www.psychogenics.com. PsychoGenics. Retrieved 29 December 2018.
  10. "Drug Receives FDA's Breakthrough Therapy Designation for Treating Individuals with Schizophrenia". Pharmacy Times. Pharmacy & Healthcare Communications, LLC. Retrieved 21 June 2019.
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