FDA Grants Fast Track Designation to Investigational Narcolepsy Treatment
The oral orexin 2 receptor agonist currently in phase 1b development for patients with narcolepsy.
The oral orexin 2 receptor agonist currently in phase 1b development for patients with narcolepsy.
The FDA has granted Orphan Drug Designation to Tris Pharma’s TRN-257, an investigational once-nightly, low-sodium oxybate therapy for the treatment of idiopathic hypersomnia. The designation recognizes the potential for this formulation to reduce nocturnal treatment burdens while offering a lower-sodium alternative for patients requiring long-term care.
The prescription-only reusable EPAP device offers two therapeutic back pressure settings to treat obstructive sleep apnea.
What can sleep physicians do when obstructive sleep apnea patients can't afford every recommended therapy?
Nexalin Technology has secured a US patent for its Deep Intracranial Frequency Stimulation (DIFS) platform, protecting its noninvasive, in-home treatment method for insomnia, anxiety, and depression through 2042. The patent reinforces the company’s strategy to expand physician-supervised, drug-free neurostimulation care via its virtual clinic model.
The medical technology company is transitioning leadership to focus on its next phase of growth and commercial traction for its obstructive sleep apnea therapy in the US market.
Avecho Biotechnology will proceed to full enrollment in its phase III insomnia trial after an independent board found no serious adverse events in an interim analysis of its TPM-enhanced CBD capsule. The company is now preparing to engage with the FDA and international regulators to determine potential commercial pathways for the treatment.
A retrospective study explores how surgical and pharmacologic weight-loss strategies stack up in cost, effectiveness, and health outcomes.
A mastery-based cognitive-behavioral model centers on "nightmare efficacy" to help clinicians create personalized treatment plans for youth.