The upcoming submission for AXS-12 (reboxetine) for cataplexy in narcolepsy follows supportive feedback from the FDA.
Key takeaways:
- Axsome Therapeutics plans to submit a New Drug Application for AXS-12 for the treatment of cataplexy in narcolepsy in January 2026.
- The decision follows the receipt of supportive pre-NDA meeting minutes from the FDA.
- AXS-12 (reboxetine) is a selective norepinephrine reuptake inhibitor and has been granted Orphan Drug Designation for narcolepsy.
- The company also reported preliminary full-year 2025 net product revenue of $638.5 million, a 66% annual growth, with its existing narcolepsy drug Sunosi generating $124.8 million.
Axsome Therapeutics will submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for AXS-12 for the treatment of cataplexy in narcolepsy.
The company anticipates completing the submission in January 2026. The decision is supported by formal pre-NDA meeting minutes from the FDA, which indicated the company’s regulatory data package is sufficient for filing. The final NDA’s acceptance is subject to the FDA’s review of the complete submission.
“We are pleased with the FDA pre-NDA meeting minutes, which allow completion of the NDA submission for AXS-12 for the treatment of cataplexy in patients with narcolepsy shortly in January 2026,” says Herriot Tabuteau, MD, CEO of Axsome, in a release. “We are excited by the potential of AXS-12 to provide a new, differentiated treatment option to patients living with this debilitating condition, if approved.”
AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. Its clinical development program for narcolepsy includes three controlled efficacy trials and a completed long-term safety trial.
The FDA has granted AXS-12 Orphan Drug Designation for the treatment of narcolepsy. The designation is for drugs intended to treat rare diseases affecting fewer than 200,000 people in the US and may entitle Axsome to seven years of marketing exclusivity upon approval.
The pipeline update comes as Axsome reported strong preliminary financial results for 2025. The company announced total net product revenue of approximately $638.5 million for the full year, a 66% increase over 2024. Revenue for Sunosi, its approved treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea, was $124.8 million for the year.
