Alkermes’ narcolepsy drug candidate alixorexton demonstrated a significant improvement in patient wakefulness during a Phase 2 clinical trial, yet the promising results are overshadowed by a concerning incidence of vision-related side effects. The trial indicated that alixorexton could enhance the duration of wakefulness for patients suffering from narcolepsy, a condition that severely impacts daily functioning and quality of life.
However, the emergence of these side effects raises critical questions about the drug’s safety profile and its potential for regulatory approval. The pharmaceutical industry is acutely aware that the presence of adverse effects can complicate the path to market, particularly in a therapeutic area where patient safety is paramount. As Alkermes navigates the regulatory landscape, the balance between efficacy and tolerability will be crucial in determining alixorexton’s future in treating narcolepsy.
