AXS-14 for Fibromyalgia

Axsome's vast pipeline includes AXS-14, (esreboxetine) a novel treatment for fibromyalgia. AXS-14 brings a new mechanism of action, a highly selective and potent norepinephrine reuptake inhibitor which was successful in phase 2 and 3 clinical trials. There are currently three FDA approved drugs to treat fibromyalgia. 

• Lyrica (2007
• Cymbalta (2008)
• Savella (2009)

Axsome currently has AXS-14 patent pending, Google Patent. If approved, the patent would expect to extend out to around 2042. Another smaller company Tonix is expected to apply for FDA approval for their fibromyalgia drug, TNX-102 SL, in the second half of 2024. Below is a chart of Axsome which has trended around the $75.00 level most of 2024. Thank you for reading.

AXS-14 for Fibromyalgia

Another positive development involving Axsome Therapeutics and drug AXS-14, for Fibromyalgia. The FDA has given the company an expedited pathway to file a New Drug Application from the already completed, and positive phase 2 and phase 3 clinical trials. The company plans to initiate the NDA process in the fourth quarter of 2022, with expected FDA approval by third quarter 2023. This adds to their pipeline of AXS-05 for MDD, and AXS-07 for Acute Migraine. Both those drugs are already going through the FDA approval process, with AXS-05 expecting an approval by August 22nd of 2021.