An asset that some investors may have overlooked came through for Axsome Therapeutics Inc., which rolled out phase III data from the trial called Symphony with AXS-12 (reboxetine), which hit the primary endpoint by significantly reducing cataplexy attacks in narcolepsy patients vs. placebo.
NLS Pharmaceutics Ltd. has entered into an exclusive worldwide license agreement with Aexon Labs Inc. granting NLS the opportunity to acquire global development and commercialization rights to Aexon’s next-generation nonsulfonamide dual orexin receptor agonists platform.
Researchers from Centessa Pharmaceuticals plc presented the preclinical characterization of ORX-750, a novel selective orexin receptor 2 (OX2R) agonist aimed to be used for the treatment of narcolepsy.
Despite its promising therapeutic efficacy in patients with narcolepsy type 1, the previously reported orally available orexin OX2 receptor (OX2R) agonist TAK-994 has also demonstrated off-target liver toxicity. Now, researchers from Takeda Pharmaceutical Co. Ltd. have reported the discovery and early evaluation of a new OX2R agonist, TAK-861, being developed for the treatment of narcolepsy and other hypersomnia disorders.
Why U.S. FDA-approved Wakix (pitolisant) has worked to treat excessive daytime sleepiness (EDS) in narcolepsy but not in idiopathic hypersomnia (IH) patients is the question that lies before Harmony Biosciences Holdings Inc., and one that the U.S. FDA will take up at a future sit-down.
Now that Avadel Pharmaceuticals plc has final U.S. FDA approval for its narcolepsy drug Lumryz, the company has priced the sodium oxybate formulation to match the cost of competitor Xywav from Jazz Pharmaceuticals plc. Avadel said it plans to charge $64.67 per gram for Lumryz. The annual cost based a 9-gram dose would be about $212,441 per patient. Three daily dose levels, 6 grams, 7.5 grams and 9 grams, were evaluated during a phase III study the final approval was based on.
While the FDA has yet to take a stance on whether risk evaluation and mitigation strategy (REMS) patents can be listed in its Orange Book, the U.S. Court of Appeals for the Federal Circuit weighed in Feb. 24 with a decisive “no” when those patents only claim a system.