Introduction
Solriamfetol, marketed under the brand name Sunosi, is a dual-acting dopamine and norepinephrine reuptake inhibitor that has been gaining significant attention for its efficacy in treating excessive daytime sleepiness (EDS) associated with various conditions. Here, we will delve into the latest updates on clinical trials, market performance, and future projections for this medication.
Clinical Trials Update
Current Indications and Ongoing Trials
Solriamfetol is currently approved for the treatment of EDS in adult patients with narcolepsy or obstructive sleep apnea (OSA)[2][3].
-
Shift Work Disorder (SWD): Axsome Therapeutics is conducting a phase 3 clinical trial, known as the SUSTAIN study, to evaluate the efficacy and safety of solriamfetol for the treatment of EDS associated with SWD. This trial aims to assess whether solriamfetol can decrease sleepiness, improve work functioning, and enhance quality of life in early-morning shift workers[1][2].
-
Binge Eating Disorder (BED): The ENGAGE phase 3 trial is underway to test the efficacy and safety of solriamfetol in treating BED. This trial is significant as it focuses on reducing binge eating episodes, a primary endpoint that aligns with patient-centric outcomes. The results of this trial are anticipated to have a substantial impact on Axsome Therapeutics' valuation and market position[4].
-
Other Indications: Solriamfetol is also being explored for potential additional indications, including attention deficit hyperactivity disorder (ADHD), major depressive disorder, and excessive sleepiness associated with other neurological conditions[2].
Market Analysis
Prescription Trends and Revenue
In the second quarter of 2024, solriamfetol saw a notable increase in prescriptions, with approximately 45,000 prescriptions written in the United States. This represents an 8% increase from the first quarter of 2024 and a 15% growth compared to the same period in 2023. The wake-promoting agent market, in contrast, grew only 4% sequentially and declined 1% year-over-year[2].
-
New Patient Initiations: During Q2 2024, more than 4,200 new patients initiated solriamfetol treatment, and about 400 new prescribers were activated. This indicates a strong adoption rate among both patients and healthcare providers[2].
-
Revenue Growth: Solriamfetol generated $22.1 million in net product revenue for Q2 2024, marking a 16% year-over-year growth. The stable payor coverage, with 95% of lives covered, further supports the medication's market presence[2].
Market Projections
Growth Potential
The market for wake-promoting agents is competitive, but solriamfetol's unique mechanism of action and demonstrated efficacy position it favorably.
-
Expanding Indications: The potential approval of solriamfetol for additional indications such as BED, ADHD, and major depressive disorder could significantly expand its market reach. The ENGAGE trial, for instance, could lead to a new standard of care for BED, a condition with limited pharmacological treatments[4].
-
Global Expansion: The in-licensing agreement with Pharmanovia allows for the exclusive marketing rights of solriamfetol in Europe and the Middle East and North Africa (MENA) regions. This partnership is expected to increase access to solriamfetol for patients globally[3].
-
Patient and Prescriber Adoption: The strong performance in new patient prescriptions and the activation of new prescribers suggest a positive trend in adoption. As more healthcare providers become familiar with solriamfetol, its market share is likely to grow[2].
Efficacy and Safety Profile
Clinical Efficacy
Solriamfetol has demonstrated clinically meaningful efficacy in improving wakefulness and reducing sleepiness in patients with narcolepsy and OSA.
-
Wakefulness and Sleepiness: Studies have shown that solriamfetol increases wakefulness and decreases sleepiness in a dose-dependent manner. In patients with narcolepsy, significant improvements in wakefulness were observed as early as week 1 and were maintained through 12 weeks[3].
-
Quality of Life: Solriamfetol has also been shown to improve patient reports of feeling better and enhance overall quality of life, as measured by the Patient Global Impression of Change (PGI-C)[3].
Safety Profile
The safety profile of solriamfetol has been evaluated in several clinical trials.
- Adverse Events: Common adverse events include headache, nausea, and anxiety. Serious adverse events are rare, and no deaths have been reported in the trials. The discontinuation rate due to adverse events is relatively low[5].
Key Takeaways
- Solriamfetol is being evaluated for new indications, including shift work disorder, binge eating disorder, ADHD, and major depressive disorder.
- Market performance is strong, with increasing prescriptions and revenue growth.
- Global expansion through partnerships like the one with Pharmanovia is expected to increase access to the medication.
- Efficacy and safety have been demonstrated in clinical trials, showing improvements in wakefulness and quality of life.
- Adoption rates among patients and prescribers are positive, indicating a favorable market trend.
FAQs
What is solriamfetol used for?
Solriamfetol, marketed as Sunosi, is used to treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy or obstructive sleep apnea (OSA).
What are the ongoing clinical trials for solriamfetol?
Ongoing trials include the SUSTAIN study for shift work disorder and the ENGAGE trial for binge eating disorder, among others.
How has the market performance of solriamfetol been in recent quarters?
Solriamfetol has seen an 8% increase in prescriptions from Q1 to Q2 2024 and a 15% growth year-over-year, with $22.1 million in net product revenue for Q2 2024.
What are the common adverse events associated with solriamfetol?
Common adverse events include headache, nausea, and anxiety, with rare serious adverse events and a low discontinuation rate due to adverse events.
Is solriamfetol available globally?
Solriamfetol is available in the United States and, through a licensing agreement with Pharmanovia, is being marketed in Europe and the MENA regions.
References
- Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder. ClinicalTrials.gov.
- Wake-Promoting Sunosi 'Continues to Grow Adoption' with 4,000+ Prescriptions. Sleep Review Magazine.
- Pharmanovia Enters In-Licensing Agreement With Axsome Therapeutics to Market and Further Develop Sunosi (solriamfetol). Business Wire.
- Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol. Stock Titan.
- Clinical Trial Results - Jazz Pharmaceuticals. Jazz Pharmaceuticals.
