Unite Narcolepsy (UN) is an initiative launched by Wake Up Narcolepsy in the summer of 2013 to mobilize the narcolepsy community in response to an invitation by the Food and Drug Administration. Earlier in the year, the FDA invited people with narcolepsy (PWN) and their care-givers to share their experiences as part of the agency’s Patient-Focused Drug Development (PDFF) initiative. Narcolepsy is the first rare disease and the fourth disease overall to be addressed in the current series of 20 patient-centered workshops.
The FDA initiative enables PWN and their loved ones to participate actively in shaping the future of narcolepsy treatment. Organizations and individuals from across the narcolepsy community have joined efforts to make the most of this landmark opportunity. UN spearheaded this effort by informing people affected by narcolepsy about the FDA invitation and preparing them to respond meaningfully to it. By encouraging and facilitating broad participation, we are honoring PWN and using the power of their testimony to ensure that patient needs are at the center of research efforts and regulatory decisions about narcolepsy treatment.
The initial product of the UN initiative was participation on September 24, 2013, in the narcolepsy public meeting at FDA headquarters in Silver Spring, MD. More than 150 PWN and their care-givers attended in person, with hundreds more participating by webcast. Many in attendance gave direct testimony about living with narcolepsy and current treatment options, and webcast participants were also able to respond.
As a result of this meeting, the FDA will produce a report reflecting the input obtained from the narcolepsy community. This will include the findings of a survey conducted by Unite Narcolepsy. The report will be posted on the FDA website and circulated to the agency’s key decision makers. it is our hope that this information will inspire creation of new patient-focused outcome measures qualified for use in drug development, and capture patient experience more systematically in clinical trials.
- Together we are increasing awareness and deepening understanding of what it’s like to live with narcolepsy.
- Together we will accelerate enhanced care.
- Together we are creating a better future for all those affected by narcolepsy.
You can read a summary of this remarkable event at HERE.
Please join us! There is still time to participate by completing the anonymous survey based on the questions FDA asked about symptoms and treatment. Survey Link.
Learn more at www.unitenarcolepsy.org.