Positive Results from Phase 3 Trial of AXS-12 in Narcolepsy Treatment
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Amylyx Pharmaceuticals' ALS drug, Relyvrio, has failed in a Phase III trial, showing no efficacy against the primary and secondary endpoints. The drug, a combination of sodium phenylbutyrate and taurursodiol, had previously been approved by the FDA in September 2022 after a second advisory committee meeting. Patient advocacy groups played a role in pressuring the FDA to reverse its initial decision. The drug had a good safety profile but did not provide any therapeutic benefit to ALS patients. Amylyx will announce its plans for the drug in the coming weeks. The failure of Relyvrio highlights the importance of efficacy and safety in drug approvals, even in the face of unmet medical need .
In other news, Axsome Therapeutics announced positive results from its Phase 3 SYMPHONY trial, showing...
#newstr #Als #Relyvrio #AmylyxPharmaceuticals #PhaseIiiTrial #Axs12 #Narcolepsy #SymphonyTrial #Cataplexy #ExcessiveDaytimeSleepiness #CognitiveFunction #AdverseEvents #OrphanDrugDesignation #Patents