AXS-07 for Acute Migraine

Axsome’s AXS-07 is designed to treat acute episodes of migraine. The drug is a combination of Meloxicam and Rizatriptan. Rizatriptan belongs in a group called triptans which are oral drugs designed to treat moderate to severe migraine headaches. AXS-07 will also compete against a newer group of oral drugs known as CGPR inhibitors similar to Allergan's Ubrogepant. The recently announced news from Axsome, was that the company met with the FDA in May, and was told that the current phase 3 clinical trial for acute migraine AXS-07 Phase 3, if successful, would be the only clinical trial needed to file a new drug application (NDA).  The clinical trial is currently being run under a Special Protocol Assessment (SPA) which was granted by the FDA prior to the trial beginning. Axsome also announced that a 12-month safety study has commenced. Patients will roll off the current phase 3 clinical trial, and into the 12 month safety study, which is a standard requirement for a new drug application to be filed with the FDA. The company is expected to file for FDA approval in the second half of 2020, which could lead to approval in 2021. The patent for AXS-07 runs into 2036.  Thank you for reading. 

NMDA Receptor Modulators for CNS Disorders

We originally wrote about this topic here NMDA Receptor Modulators for Depression. There are now several companies interested in bringing a variety of NMDA drugs into the clinic, either as mono-therapy or coupled with enhancers.  Let's have a look at some of the companies, their drug, and indications that they are targeting.

Avanir:  Otsuka

AVP-786  Dextromethorphan + Quinidine
Ph 3  Agitation in Alzheimer's Disease
Ph 2  Residual Schizophrenia
Ph 2  Major depressive disorder (adjunct)

Axsome: AXSM

AXS-05  Dextromethorphan + Bupropion  

Ph 3 Treatment resistant depression

Ph 1 Agitation in Alzheimer's Disease

Cerecor:  CERC
CERC-301  NR2B Specific NMDA antagonist oral
Ph 2 Major depressive disorder (adjunct)

JNJ / Janssen
Esketamine  intranasal
Phase 3 adjunct with anti-depressant for TRD

Naurex:  Allergan
NMDA receptor partial agonist with selective properties
Ph 2 NRX-1074  IV
Ph 1 NRX-1074 Oral
Ph 3 GLYX-13 (Rapastinel) Weekly IV Major Depressive disorder

Vistagen:  VSTA
AV-101  NMDA selective antagonist oral
Ph 2 AV-101 Major depressive disorder 

Over the next couple years, we should see some meaningful clinical readouts from some of these companies.  Potentially NMDA drugs may provide for a more efficacious and safer, sustainable therapy, aside from current antidepressants for some of the above indications. Thank you for reading.