Solriamfetol

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Solriamfetol
Solriamfetol.svg
Names
Trade namesSunosi
Other namesSKL-N05, ADX-N05, ARL-N05, YKP10A, R228060, and JZP-110; (R)-2-amino-3-phenylpropylcarbamate hydrochloride
  • (2R)-2-Amino-3-phenylpropyl carbamate
Clinical data
Drug classNorepinephrine–dopamine reuptake inhibitor[1]
Main usesExcessive sleepiness from narcolepsy or obstructive sleep apnea[1]
Side effectsHeadache, nausea, anxiety, trouble sleeping[1]
InteractionsMAO inhibitors[2]
Pregnancy
category
  • US: N (Not classified yet)
Routes of
use
By mouth
External links
AHFS/Drugs.comMonograph
US NLMSolriamfetol
MedlinePlusa619040
Legal
License data
Legal status
Pharmacokinetics
Bioavailability~95%[1]
Protein binding13.3–19.4%[1]
MetabolismMinimal[1]
Elimination half-life~7.1 hours[1]
ExcretionUrine (95% unchanged)
Chemical and physical data
FormulaC10H14N2O2
Molar mass194.234 g·mol−1
3D model (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 medication used to treat excessive sleepiness associated with narcolepsy and obstructive sleep apnea.[1] It is taken by mouth.[2]

Common side effects include headache, nausea, anxiety, and trouble sleeping.[1] Other side effects may include increased blood pressure and abuse.[2] It interacts with monoamine oxidase (MAO) inhibitors.[2] Safety in pregnancy and breastfeeding is unclear.[4] It is a norepinephrine–dopamine reuptake inhibitor (NDRI); though how it improves wakefulness is not entirely clear.[1][5]

Solriamfetol was approved for medical use in the United States in 2019 and Europe in 2020.[2][5] In the United States its costs about 690 USD per month as of 2021.[6] In the United States it is a Schedule IV controlled substance.[1]

Medical use

Dosage

It is taken at a dose of 37.5 to 150 mg once per day.[1]

Pharmacology

Pharmacodynamics

Solriamfetol is a norepinephrine–dopamine reuptake inhibitor (NDRI).[1] It binds to the dopamine transporter and the norepinephrine transporter with affinities (Ki) of 14.2 μM and 3.7 μM, respectively).[1] It inhibits the reuptake of dopamine and norepinephrine with IC50 values of 2.9 μM and 4.4 μM, respectively.[1] It has weak affinity for the serotonin transporter (Ki = 81.5 μM) and does not appreciably inhibit serotonin reuptake (IC50 > 100 μM).[1] Solriamfetol has no appreciable affinity for a variety of other targets, including the dopamine, serotonin, adrenergic, GABA, adenosine, histamine, orexin, benzodiazepine, and acetylcholine receptors.[1]

Pharmacokinetics

The elimination half-life of solriamfetol is about 7.1 hours.[1]

Chemistry

It is derived from d-phenylalanine and its chemical name is (R)-2-amino-3-phenylpropylcarbamate hydrochloride.[7]

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.[8] Aerial ran two Phase II trials of the drug in narcolepsy[9] 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.[8][10]

In 2019, solriamfetol was approved in the United States to improve wakefulness in adults with narcolepsy or obstructive sleep apnea (OSA).[11][12] It was granted orphan drug designation.[13]

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).[11] The trials were conducted in Canada, Europe, and the United States.[11]

Solriamfetol was approved for medical use in the European Union in January 2020.[3]

Society and culture

Names

During development it has been called SKL-N05, ADX-N05, ARL-N05, and JZP-110.[14]

Legal status

In the United States, solriamfetol is a Schedule IV controlled substance,[1] meaning that it has an accepted medical use and a low potential for abuse, but that abuse may lead to physical or psychological dependence.[15] A prescription is required, and can only be refilled up to five times in a six-month period.[16] In countries of the European Union, a prescription is required.[3]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 1.14 1.15 1.16 1.17 1.18 1.19 "Sunosi- solriamfetol tablet, film coated". DailyMed. 16 October 2019. Retrieved 24 November 2019.
  2. 2.0 2.1 2.2 2.3 2.4 "Solriamfetol Monograph for Professionals". Drugs.com. Retrieved 14 October 2021.
  3. 3.0 3.1 3.2 "Sunosi EPAR". European Medicines Agency (EMA). 12 November 2019. Retrieved 26 September 2020.
  4. "Solriamfetol (Sunosi) Use During Pregnancy". Drugs.com. Retrieved 14 October 2021.
  5. 5.0 5.1 "Sunosi". Retrieved 14 October 2021.
  6. "Sunosi Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 14 October 2021.
  7. Abad VC, Guilleminault C (2017). "New developments in the management of narcolepsy". Nature and Science of Sleep. 9: 39–57. doi:10.2147/NSS.S103467. PMC 5344488. PMID 28424564.
  8. 8.0 8.1 Ji-young S (5 March 2018). "SK Biopharmaceuticals' narcolepsy drug on track to hitting US market". The Korea Herald.
  9. Sullivan SS, Guilleminault C (2015). "Emerging drugs for common conditions of sleepiness: obstructive sleep apnea and narcolepsy". Expert Opinion on Emerging Drugs. 20 (4): 571–82. doi:10.1517/14728214.2015.1115480. PMID 26558298. S2CID 7951307.
  10. Garde D (14 January 2014). "Jazz bets up to $397M on Aerial's narcolepsy drug". FierceBiotech.
  11. 11.0 11.1 11.2 "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.
  12. "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.
  13. "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.
  14. "Solriamfetol - Jazz Pharmaceuticals/SK Biopharmaceuticals". AdisInsight. Retrieved 15 April 2018.
  15. 21 U.S.C. § 812 – Schedules of controlled substances
  16. "Manuals – Practitioner's Manual – SECTION V". Retrieved 2014-01-07

External links

External sites:
Identifiers: