HETLIOZ® became the first approved treatment for Non-24-Hour Sleep-Wake Disorder by the United States (U.S.) Food and Drug Administration on January 31, 2014. Since HETLIOZ® is currently only available in the U.S. and to satisfy requests from physicians outside of the U.S. who are seeking treatment on behalf of their patients, Vanda has created an expanded access program for HETLIOZ® (HETLIOZAccess®). This program is available for patients who meet the eligibility criteria for the expanded access program.
HETLIOZAccess® will be administered by a third party, Idis, and is available to patients in certain countries outside of the U.S. and its territories. Physicians outside of the U.S. may contact Idis by phone here or via email at firstname.lastname@example.org.
Expanded access programs are for patients who have a serious or immediately life-threatening disease or condition for which no comparable or satisfactory alternate therapy is available. HETLIOZ® is not approved for use by any other national health authority outside of the U.S. and Europe. HETLIOZAccess® is currently available to patients who are non-U.S. residents. Only physicians can enroll patients in the program. Patients should work through their physician to determine if they are eligible to enroll. This is not a clinical trial.