Solriamfetol

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Solriamfetol
Clinical data
Trade namesSunosi
Other namesSKL-N05, ADX-N05, ARL-N05, YKP10A, R228060, and JZP-110; (R)-2-amino-3-phenylpropylcarbamate hydrochloride
AHFS/Drugs.comMonograph
MedlinePlusa619040
License data
Routes of
administration		By mouth
Drug classNorepinephrine–dopamine reuptake inhibitors
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability~95%[3]
Protein binding13.3–19.4%[3]
MetabolismMinimal[3]
Elimination half-life~7.1 hours[3]
ExcretionUrine (95% unchanged)
Identifiers
  • (2R)-2-Amino-3-phenylpropyl carbamate
JSmol)
  • C1=CC=C(C=C1)C[C@H](COC(=O)N)N
  • InChI=1S/C10H14N2O2/c11-9(7-14-10(12)13)6-8-4-2-1-3-5-8/h1-5,9H,6-7,11H2,(H2,12,13)/t9-/m1/s1
  • Key:UCTRAOBQFUDCSR-SECBINFHSA-N

Solriamfetol, sold under the brand name Sunosi, is a

excessive sleepiness related to narcolepsy and sleep apnea.[3][5][6] It is taken by mouth.[3]

Common side effects of solriamfetol include headache, nausea, anxiety, and trouble sleeping.[3] It is a norepinephrine–dopamine reuptake inhibitor (NDRI) and is thought to work by increasing levels of the neurotransmitters norepinephrine and dopamine in the brain.[3][5]

The drug was discovered by a subsidiary of SK Group, which licensed rights outside of eleven countries in Asia to Aerial Pharma in 2011.[7] In addition to its approved indication of excessive sleepiness, solriamfetol is under development for certain other uses including the treatment of attention deficit hyperactivity disorder (ADHD), binge eating disorder, and circadian rhythm sleep disorders.[8]

Medical uses

Solriamfetol is used to promote

wakefulness-promoting agents including modafinil, armodafinil, and pitolisant.[9]

Available forms

Solriamfetol is available in the form of 75 and 150 mg oral tablets.[3]

Side effects

dry mouth, increased sweating, abdominal pain, constipation, and diarrhea.[3]

Misuse potential

Solriamfetol at higher-than-approved doses—specifically doses of 300, 600, and 1,200 mg, which are 2 to 4 times the maximum recommended dose—produces

misuse potential and is a controlled substance in the United States.[3] However, solriamfetol showed less misuse potential than Schedule II controlled stimulants like amphetamine and cocaine.[10] Consequently, the misuse potential of solriamfetol was rated as low and it was placed in the Schedule IV controlled substance category alongside phentermine.[10]

Pharmacology

Pharmacodynamics

Solriamfetol is a

benzodiazepine, and acetylcholine receptors.[3]

Pharmacokinetics

The

renal impairment.[3] Approximately 95% of a dose of solriamfetol is eliminated in urine as unchanged solriamfetol and 1% or less is eliminated as the minor inactive metabolite N-acetylsolriamfetol.[3]

Chemistry

Solriamfetol is derived from d-phenylalanine and its chemical name is (R)-2-amino-3-phenylpropylcarbamate.[11]

History

The drug was discovered by a subsidiary of SK Group, which licensed rights outside of eleven countries in Asia to Aerial Pharma in 2011.[7] Aerial ran two Phase II trials of the drug in narcolepsy[12] before selling the license to solriamfetol to Jazz in 2014; Jazz Pharmaceuticals paid Aerial $125 million up front and will pay Aerial and SK up to $272 million in milestone payments, and will pay double-digit royalties to SK.[7][13]

In 2019, solriamfetol was approved in the United States to improve wakefulness in adults with narcolepsy or obstructive sleep apnea (OSA).[14][15] It was granted orphan drug designation.[16]

The U.S. Food and Drug Administration (FDA) approved solriamfetol based primarily on evidence from five clinical trials (Trial 1/NCT02348593, Trial 2/NCT02348606, Trial 3/NCT02348619, Trial 4/NCT02348632, Trial 5 NCT01681121) of 622 patients with narcolepsy or obstructive sleep apnea (OSA).[14] The trials were conducted in Canada, Europe, and the United States.[14]

Solriamfetol was approved for medical use in the European Union in January 2020.[4]

In March 2022, it was announced that Axsome Therapeutics would be acquiring Solriamfetol, under the brand name Sunosi, from Jazz Pharmaceuticals, for an upfront sum of $53 million. Jazz will receive a high single-digit royalty on Axsome's U.S. net sales of Sunosi in the current indication, and a mid-single-digit royalty in the future indications. Axsome will also assume the commitments of Jazz to SK Biopharmaceuticals and Aerial Biopharma.[17]

Society and culture

Names

During development it has been called SKL-N05, ADX-N05, ARL-N05, and JZP-110.[8]

Legal status

In the United States, solriamfetol is a Schedule IV controlled substance,[3] meaning that it has an accepted medical use and a low potential for abuse, but that abuse may lead to physical or psychological dependence.[18] A prescription is required, and can only be refilled up to five times in a six-month period.[19] In countries of the European Union, a prescription is required.[4]

Research

Solriamfetol is under development for the treatment of

depressive disorders, but development for this indication was discontinued.[8]

References

  1. ^ "Summary Basis of Decision (SBD) for Sunosi". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  2. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  3. ^ a b c d e f g h i j k l m n o p q r s t u v w x y z aa ab ac ad "Sunosi – solriamfetol tablet, film coated". DailyMed. 16 October 2019. Retrieved 24 November 2019.
  4. ^ a b c "Sunosi EPAR". European Medicines Agency (EMA). 12 November 2019. Retrieved 26 September 2020.
  5. ^
    S2CID 215605290
    .
  6. S2CID 53106520
    .
  7. ^ a b c Ji-young S (5 March 2018). "SK Biopharmaceuticals' narcolepsy drug on track to hitting US market". The Korea Herald.
  8. ^ a b c d e "Solriamfetol – Jazz Pharmaceuticals/SK Biopharmaceuticals". AdisInsight. Retrieved 13 October 2023.
  9. S2CID 258558603
    .
  10. ^ a b "Federal Register :: Request Access".
  11. PMID 28424564
    .
  12. S2CID 7951307
    .
  13. ^ Garde D (14 January 2014). "Jazz bets up to $397M on Aerial's narcolepsy drug". FierceBiotech.
  14. ^ a b c "Drug Trials Snapshots: Sunosi". U.S. Food and Drug Administration (FDA). 16 April 2019. Archived from the original on 28 September 2019. Retrieved 24 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  15. ^ "Drug Approval Package: Sunosi". U.S. Food and Drug Administration (FDA). 29 April 2019. Retrieved 24 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  16. ^ "Solriamfetol Orphan Drug Approval". U.S. Food and Drug Administration (FDA). Retrieved 24 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  17. NASDAQ
    . Retrieved 28 March 2022.
  18. ^ 21 U.S.C. § 812 – Schedules of controlled substances
  19. ^ "Manuals – Practitioner's Manual – Section V". Archived from the original on 7 January 2014. Retrieved 30 May 2021. Retrieved 2014-01-07
  20. ^
    S2CID 263715808
    .
  21. PMID 33870884
    .
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