Expanded Access Policy
Apnimed is a clinical-stage biotechnology company focused on developing novel, oral pharmaceuticals to treat Obstructive Sleep Apnea. Our proprietary approach recognizes that OSA is largely a neurological disease, and our lead therapies are designed to target, with simple orally dosed medicines, the key underlying neurobiological mechanisms that lead to airway obstruction. Our clinical-stage candidates are being developed to address serious conditions and unmet medical need.
Expanded Access refers to the use of an investigational drug outside of a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient who lacks available therapeutic alternatives. Expanded access is different from a clinical trial in which the primary purpose is to collect extensive safety and efficacy data to support submission of an application to the U.S. Food and Drug Administration (FDA) to market a drug.
Apnimed believes that the most appropriate way for patients to access our investigational products is by participating in our clinical trials, which are managed by medical experts and are designed to determine whether the investigational products are safe and effective. Therefore, Apnimed is not accepting expanded access requests at this time. Apnimed’s clinical trials provide insight to the mechanism of action, safety and efficacy of these products. Our 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. Patients who are interested in participating in one of our trials are encouraged to discuss their specific needs with their physician. Information regarding our ongoing trials can be accessed at www.clinicaltrials.gov.
In accordance with the 21st Century Cures Act, this policy may be revised at any time. Should you have additional questions, please reach out to your physician or write to email@example.com.