This page uses content from Wikipedia and is licensed under CC BY-SA.

Solriamfetol

Solriamfetol
Solriamfetol.svg
Clinical data
Trade namesSunosi
Other namesSKL-N05, ADX-N05, ARL-N05, YKP10A, R228060, and JZP-110; (R)-2-amino-3-phenylpropylcarbamate hydrochloride
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability~95%
Protein binding13.3–19.4%
Metabolismnegligible
Elimination half-life~7.1 h
Excretionurine (95% unchanged)
Identifiers
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC10H14N2O2
Molar mass194.234 g/mol g·mol−1
3D model (JSmol)

Solriamfetol, sold under the brand name Sunosi, is a medication used for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea.[1]

Common side effects include headache, nausea, anxiety, and trouble sleeping.[1] It is a norepinephrine–dopamine reuptake inhibitor (NDRI). It is derived from phenylalanine and its chemical name is (R)-2-amino-3-phenylpropylcarbamate hydrochloride.[2]

The drug was discovered by a subsidiary of SK Group, which licensed rights outside of 11 countries in Asia to Aerial Pharma in 2011.[3]

History

The drug was discovered by a subsidiary of SK Group, which licensed rights outside of 11 countries in Asia to Aerial Pharma in 2011.[3] Aerial ran two Phase II trials of the drug in narcolepsy[4] 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.[3][5]

In March 2019 the FDA accepted SK's and Jazz' NDA for use of solriamfetol to treat excessive sleepiness in people with narcolepsy or obstructive sleep apnea; the drug has an orphan designation for narcolepsy.[3][6]

Names

During development it has been called SKL-N05, ADX-N05, ARL-N05, and JZP-110.[6]

Research

Solriamfetol had also been tested in animal models of depression, but as of 2017 that work had not been advanced to clinical trials.[7]

See also

References

  1. ^ a b "SUNOSI™ (solriamfetol) Tablets, for Oral Use. Full Prescribing Information" (PDF). Jazz Pharmaceuticals. 2019. Retrieved 21 March 2019.
  2. ^ 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.
  3. ^ a b c d Ji-young, Sohn (5 March 2018). "SK Biopharmaceuticals' narcolepsy drug on track to hitting US market". The Korea Herald.
  4. ^ 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.
  5. ^ Garde, Damian (January 14, 2014). "Jazz bets up to $397M on Aerial's narcolepsy drug". FierceBiotech.
  6. ^ a b "Solriamfetol - Jazz Pharmaceuticals/SK Biopharmaceuticals". AdisInsight. Retrieved 15 April 2018.
  7. ^ de Biase, S; Nilo, A; Gigli, GL; Valente, M (August 2017). "Investigational therapies for the treatment of narcolepsy". Expert Opinion on Investigational Drugs. 26 (8): 953–963. doi:10.1080/13543784.2017.1356819. PMID 28726523.