Axsome Therapeutics, Inc. — Sunosi FDA Review (NDA211230, ORIG 1, 2019)
Axsome Therapeutics, Inc. · 2019 · FDA Review (openFDA) · company profile →
Report summary
This report details the FDA's clinical review of Solriamfetol (Sunosi) for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea. Multiple clinical trials (e.g., ADX-N05-202, 14-002, 14-003, 14-004, 14-005) demonstrated statistically significant efficacy in improving wakefulness and reducing sleepiness compared to placebo, with dose-dependent effects observed, particularly at 150mg and 300mg doses. Safety concerns include dose-dependent increases in blood pressure and heart rate, QT interval prolongation at higher doses, and common adverse events like insomnia, headache, and anxiety. Serious adverse events, including cardiovascular events and psychiatric issues, were noted. The drug is classified as a Schedule IV controlled substance. The review also discusses regulatory aspects, including orphan drug designation and postmarketing study recommendations for pregnancy and lactation.
Key findings — cited to the page
| Irritability, agitation (placebo group) | 0.8% | Study 14-003 · p.195 |
| TEAEs in Study ADX-N05-202 (Irritability, agitation, solriamfetol combined) | 9.1% | ADX-N05-202 · p.189 |
| Irritability, agitation (all Solriamfetol group) | 2.7% | Study 14-005 (Narcolepsy) · p.193 |
| Irritability, agitation (all Solriamfetol group) | 3.6% | Study 14-005 (OSA) · p.198 |
| Irritability, agitation (all Solriamfetol group) | 3.1% | Study 14-003 · p.195 |
| TEAEs in Study ADX-N05-202 (Irritability, agitation, placebo) | 2.0% | ADX-N05-202 · p.189 |
| Review Completion Date | December 20, 2018 | · p.23 |
| PDUFA Goal Date | December 20, 2018 | · p.23 |
| Proposed Dosing Regimen | 37.5 mg, 75 mg, 150 mg mg | · p.23 |
| Priority or Standard | Standard | · p.23 |
| Review Completion Date | 19 March 2019 | · p.2 |
| Application Number | 211230Orig1s000 | · p.1 |
Source: Axsome Therapeutics, Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →