Axsome Therapeutics released phase 3 clinical data with AXS-07 for the treatment of acute migraine, for patients with an inadequate response to prior treatments.
The clinical trial met the two co-primary endpoints; Pain-Free at 2 hours after dose, and Absent most Bothersome Symptoms 2 hours after dose versus placebo. The clinical trial can be found here Momentum Phase 3. The trial also compared AXS-07 to Rizatriptan (a well known and effective generic drug for acute migraine) for these tough to treat patients, who have not responded to prior treatments. Comparisons below are AXS-07 versus Rizatriptan.
- Sustained pain freedom from 2 to 24 hours after dosing. 16.1% vs 11.2% p=0.038
- Sustained pain relief from 2 to 24 hours after dosing. 53.3% vs 43.9% p=0.006
- Sustained pain relief from 2 to 48 hours after dosing. 46.5% vs 36.5% p=0.003
- Rescue medication was used for 23.0% of AXS-07 patients vs 34.7% p=0.001
- Patient Global Impression of Change, AXS-07 vs Rizatriptan. p=0.022
- Return to normal function at 24 hours. p=0.027
The clinical trial was a success, as AXS-07 above, compared well to the generic acute migraine drug Rizatriptan. The safety profile of AXS-o7 was similar to placebo. The company plans to file an NDA (new drug application) in the second half of 2020.
Axsome Therapeutics (AXSM) is higher today after releasing phase 3 results with AXS-05 for the indication of Major Depressive Disorder or (MDD). The press release is here, AXS-05 Achieves Primary Endpoint in Gemini Phase 3. Some major points from the outstanding results are as follows.
- AXS-05 at week 6 versus placebo p=0.002
- Rate of remission of depression week 6 versus placebo p=0.001
- Week 1 AXS-05 versus placebo p=0.007
All scores are based on the Montgomery-Asberg Depression Rating Scale or MADRS. The phase 3 clinical trial details can be found here NCT04019704. The company will file for FDA approval in the second half of 2020 for the indication of MDD, and potentially get approved for that indication in the first half of 2021. Below is the chart of the stock that appreciated +70% today.
Axsome Therapeutics (AXSM) today, announced the results of their phase 2 clinical trial with drug AXS-12 (reboxetine) for Narcolepsy. The clinical trial is here clinicaltrials.gov. The trial results were better than anticipated. All comparisons of AXS-12 versus placebo were statistically significant.
- Reduction in Cataplexy attacks compared to placebo p=0.001
- Reduced daytime sleepiness compared to placebo p=0.003
- Improved cognitive function compared to placebo p=0.001
- Sleep quality and sleep related symptoms compared to placebo p=0.007
AXS-12 was safe and well tolerated. Chart below.
