JZP-361

JZP-361

JZP-361 is a novel investigational drug developed for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy and obstructive sleep apnea (OSA). It is being developed by Jazz Pharmaceuticals, a company known for its focus on sleep medicine and neuroscience.

Pharmacology

JZP-361 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). By inhibiting the reuptake of these neurotransmitters, JZP-361 increases their availability in the synaptic cleft, which enhances wakefulness and alertness. This mechanism is similar to other wake-promoting agents, but JZP-361 is designed to have a more favorable side effect profile.

Clinical Trials

JZP-361 is currently undergoing clinical trials to evaluate its efficacy and safety in patients with EDS due to narcolepsy and OSA. Early phase trials have shown promising results in terms of improving wakefulness and reducing sleepiness without significant adverse effects.

Phase I Trials

The Phase I trials focused on assessing the safety, tolerability, and pharmacokinetics of JZP-361 in healthy volunteers. These studies established the appropriate dosing regimen and identified potential side effects.

Phase II Trials

In Phase II trials, JZP-361 was tested in patients with narcolepsy and OSA. The primary endpoint was the reduction in EDS as measured by the Epworth Sleepiness Scale (ESS) and Maintenance of Wakefulness Test (MWT). Results indicated a significant improvement in wakefulness compared to placebo.

Phase III Trials

Phase III trials are ongoing and aim to confirm the efficacy and safety of JZP-361 in a larger patient population. These trials will provide the data necessary for regulatory approval.

Side Effects

Common side effects observed in clinical trials include headache, nausea, and insomnia. JZP-361 is generally well-tolerated, but long-term safety data are still being collected.

Regulatory Status

As of the latest update, JZP-361 is not yet approved by the FDA or other regulatory bodies. Jazz Pharmaceuticals is working towards submitting a New Drug Application (NDA) pending successful completion of Phase III trials.

Potential Impact

If approved, JZP-361 could offer a new treatment option for patients with EDS due to narcolepsy and OSA, potentially improving quality of life and daily functioning.

Also see

• Narcolepsy
• Obstructive Sleep Apnea
• Dopamine and Norepinephrine Reuptake Inhibitors
• Excessive Daytime Sleepiness
• Jazz Pharmaceuticals