Axsome Therapeutics is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders. In order to obtain approval for these therapies, Axsome is investigating their safety and efficacy in clinical trials as required by the United States Food and Drug Administration (FDA) and other regulatory agencies worldwide.
Expanded access programs, also known as pre-approval access and compassionate use, are potential pathways for patients to receive investigational medications that are not approved by the FDA but that may be beneficial for life-threatening or serious conditions. Under these programs, patients who are unable to participate in a clinical trial are provided the investigational medication outside of the comprehensive safety and efficacy evaluations that occur during clinical trials. Axsome recognizes the value that expanded access programs provide and is implementing the following policy:
Expanded Access Policy
Axsome believes that the most appropriate way to receive investigational medication is through one of our clinical trials, and as such we do not provide access to our investigational medications outside of our clinical trials. Our clinical trials help ensure that important safety and efficacy monitoring practices are in place which both help protect patients and ensure that product development is proceeding as quickly as possible, allowing for the widest possible distribution of our products to patients in need of treatment.
Contact Information for Requests
In accordance with our Expanded Access Policy, Axsome will only provide access to our investigational medications through participation in our clinical trials at this time. Patients and physicians are encouraged to visit our ClinicalTrials.gov listings, linked below, for information about our ongoing trials. If you have additional questions regarding our policy, please have your physician contact MedInfo@Axsome.com. We anticipate acknowledging receipt of requests sent to this email within three (3) business days.
Axsome’s Expanded Access Policy may be revised at any time, in line with the 21st Century Cures Act. Hyperlinks to ClinicalTrials.gov listings will be updated after the trial record becomes available. This policy is current as of April 9, 2019.
Ongoing Clinical Trials
AXS-05 (bupropion / dextromethorphan)
- Treatment Resistant Depression (STRIDE): https://clinicaltrials.gov/ct2/show/NCT02741791
Agitation in Alzheimer’s Disease (ADVANCE): https://clinicaltrials.gov/ct2/show/NCT03226522
Smoking Cessation (Duke University Trial): https://clinicaltrials.gov/ct2/show/NCT03471767
AXS-07 (MoSEIC™ meloxicam / rizatriptan)
- Migraine (MOMENTUM): https://clinicaltrials.gov/ct2/show/NCT03896009
- Cataplexy in Narcolepsy (CONCERT): https://clinicaltrials.gov/ct2/show/NCT03881852