Pharmanovia — Sunosi EMA EPAR public assessment report (EMEA/H/C/004893, 2020)
Pharmanovia · 2020 · EMA EPAR public assessment report
Report summary
The EMA's assessment of Sunosi (solriamfetol) for narcolepsy and obstructive sleep apnoea (OSA) concluded with a positive opinion for marketing authorization. Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, demonstrated dose-dependent improvements in wakefulness (MWT) and reduced excessive daytime sleepiness (ESS) in Phase III trials. Non-clinical studies confirmed its wake-promoting properties and safety profile. Clinical safety concerns include dose-dependent increases in blood pressure and heart rate, particularly at higher doses, and other common adverse events like headache and nausea. Risk minimization strategies address cardiovascular and psychiatric events, abuse potential, and reproductive toxicity, with post-marketing surveillance planned.
Key findings — cited to the page
| NOAEL for F1 reproduction | 110 mg/kg/d | · p.33 |
| CHMP opinion for marketing authorisation | positive | Sunosi · European Union · p.9 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 14 September 2017 | European Union · p.7 |
| Indication applied for | to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy) or obstructive sleep apnoea (OSA) | · p.7 |
| Scientific Advice from CHMP on development | 09 November 2017 | · p.8 |
| Application for Marketing Authorisation submission date | 8 November 2018 | Sunosi · European Union · p.7 |
| MWT change from baseline (OSA, 150mg vs placebo) | 10.96 min | 14-003 · p.121 |
| ESS change from baseline (narcolepsy, 150mg vs placebo) | -5.4 | 14-002 · p.121 |
| MWT LS mean difference vs placebo | 11.16 minutes | randomized withdrawal study 14-004 · p.117 |
| Decreased appetite incidence | 9.08 % | · p.121 |
| Anxiety incidence | 6.81 % | · p.121 |
| Nausea incidence | 9.25 % | · p.121 |
Source: Pharmanovia ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →