Solriamfetol hydrochloride is under clinical development by Axsome Therapeutics and currently in Phase III for Attention Deficit Hyperactivity Disorder (ADHD). According to GlobalData, Phase III drugs for Attention Deficit Hyperactivity Disorder (ADHD) have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Solriamfetol hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Solriamfetol hydrochloride overview

Solriamfetol hydrochloride (Sunosi) was a phenylalanine derivative, acts as an wake-promoting agent. It is formulated as film coated tablets for oral route of administration. Sunosi is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA), and to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive  sleep  apnoea (OSA)  whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

Solriamfetol hydrochloride (SKL-N05/JZP-110/ADX-N05) is under development for the treatment of attention deficit hyperactivity disorder (ADHD), excessive sleep in idiopathic Parkinson’s disease, obstructive sleep apnea, binge eating disorder (BED), major depressive disorder, shift work disorder, fatigue. It is administered orally. The drug candidate is an optically pure phenylalanine derivative. The adrenergic agent was also under development for the treatment of drug addiction and major depressive disorder, pediatric subjects with narcolepsy.

Axsome Therapeutics overview

Axsome Therapeutics (Axsome) is a biopharmaceutical company that develops and commercializes therapies for the treatment of central nervous system (CNS) disorders. The company’s pipeline products include AXS-05, for the treatment of resistant depression, smoking cessation and agitation in Alzheimer’s disease, AXS-07-migraine, AXS-12-narcolepsy, and AXS-14, for the treatment of fibromyalgia. Its other products include sunosi and auvelity. The company supplies its products through internal sales, distributors and an internal marketing group in the US and outside the US. Axsome is headquartered in New York, the US.

For a complete picture of Solriamfetol hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.