Zynerba is dedicated to developing innovative transdermal pharmaceutically-manufactured cannabinoid treatments for patients with significant unmet medical needs. To do this, we conduct clinical trials to assess the safety and efficacy of investigational medicines. If proven in clinical trials we can obtain the necessary approvals from regulatory authorities to provide patients with broad access to these medicines. In some circumstances, patients with serious or life-threatening diseases or conditions who do not have access to clinical trials may seek special access to investigational medicines outside of a clinical trial setting. These situations are often referred to as early access, expanded access or compassionate use.
We share the urgency of patients and families seeking new treatments and understand some may be interested in accessing these investigational medications, before approval by the U.S. Food and Drug Administration (FDA). It is also in the best interest of the community of all potential patients for a new medicine to advance through the FDA approval process. We are committed and diligently working to complete the clinical trial process in order to seek FDA approval to market our products. Therefore, after careful consideration of the regulatory processes, benefit and risk profile of our investigational medicines as currently understood and feasibility of sustaining an early access program, we will not offer our investigational medicines through an early access program. The only pathway for access to these investigational medicines, prior to regulatory approval, is through a clinical trial.
Patients who are interested in accessing our investigational medicines may be eligible for a clinical trial, and we encourage them to talk with their doctor to determine potential benefits, risks, and feasibility. In addition, patients and families can search www.clinicaltrials.gov for planned, active, recruiting and ongoing trials.
For additional information patients, families, or physicians may email our medical department at MedicalInformation@zynerba.com.