Alkermes plc ((ALKS)) announced an update on their ongoing clinical study.
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Alkermes plc is conducting a long-term clinical study titled An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia. The study aims to evaluate the safety and effectiveness of ALKS 2680 in treating Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia, conditions that significantly impact sleep and daily functioning.
The intervention being tested is ALKS 2680, an oral tablet available in various dosages (4mg, 6mg, 8mg, 10mg, 14mg, and 18mg). This drug is designed to improve wakefulness and manage symptoms associated with these sleep disorders.
The study follows an interventional design with a non-randomized, parallel assignment model. It is open-label, meaning no masking is involved, and its primary purpose is treatment. This design allows researchers to observe the drug’s effects over an extended period.
The study began on January 6, 2025, with the latest update submitted on October 10, 2025. These dates are crucial as they mark the study’s progress and ongoing data collection, which is vital for future analysis and potential regulatory approval.
This study update could positively influence Alkermes’ stock performance and investor sentiment, especially if the results demonstrate significant benefits of ALKS 2680. As the company competes in the sleep disorder treatment market, successful outcomes may enhance its competitive position.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.