Supernus Pharmaceuticals announced positive results from a Phase IIa study of SPN-820, a first-in-class intracellular modulator of mTORC1, as an adjunctive treatment for major depressive disorder (MDD). The study demonstrated that SPN-820 was safe and effective in adults with MDD, suggesting its potential for a rapid-onset antidepressant effect.
The investigational drug is designed to provide a faster response compared to traditional antidepressants, which often take weeks to show noticeable effects. The trial's findings highlight a significant unmet need in the treatment of depression, where rapid symptom relief can greatly improve patient outcomes.
In other news, the FDA expanded the approval of sodium oxybate (Lumryz) for cataplexy or excessive daytime sleepiness to include children with narcolepsy ages 7 years and up, Avadel Pharmaceuticals announced. This approval offers a new treatment option for younger patients suffering from narcolepsy.
Furthermore, a real-world analysis indicated that adults with a history of opioid use disorder or alcohol use disorder who were prescribed a GIP and/or GLP-1 receptor agonist for type 2 diabetes or obesity experienced significantly lower rates of opioid overdose and alcohol intoxication. This suggests a potential role for these medications in managing addiction-related risks.
Lykos Therapeutics is planning an additional phase III trial and a potential independent third-party review of prior phase III clinical data following a recent meeting with the agency after the FDA rejected Lykos Therapeutics' MDMA-assisted post-traumatic stress disorder therapy in August.
