Nacuity Pharmaceuticals, Inc., is a clinical-stage biotechnology company and leader in innovative treatments for diseases or conditions involving oxidative stress. Our clinical trials are the primary avenues to gain access to NACUITY’s investigational medicinal products. These clinical trials provide the most effective way to assess how our investigational medicinal products may prevent and/or treat diseases or conditions involving oxidative stress to support regulatory approval. NACUITY encourages patients to speak with their treating physicians about participating in a clinical trial, when possible. Additional information about NACUITY’s ongoing clinical trials can be found by accessing https://clinicaltrials.gov.
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medicinal product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available (https://www.fda.gov/news-events/public-health-focus/expanded-access). Expanded access may be appropriate when all the following apply:
- Patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Investigational medicinal products have not yet been approved or cleared by the U.S. Food and Drug Administration (FDA) and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medicinal product may, or may not, be effective in the treatment of the condition, and use of the agent may cause unexpected serious side effects.
As a general policy, NACUITY will not provide an investigational medicinal product to patients until a dosage regimen has been established for the agent, preliminary data exists that that agent has some evidence of effectiveness in a particular indication, and the agent is found to be safe as a result of a risk-benefit evaluation.
At this time NACUITY is not currently making any of its investigational medicinal products available on an Expanded Access basis prior to regulatory approval anywhere in the world. NACUITY may reconsider making one or more of its investigational medicinal products available through an Expanded Access Program in the future. All requests for Expanded Access must come from a patient’s treating physician and will be evaluated and responded to on a case-by-case basis. A patient’s treating physician can expect acknowledgement of receipt of their request within 5 business days.