The BreatheDMD program will enable participating physicians to obtain idebenone, an investigational medicine, for eligible patients in the US suffering from DMD. A number of centers throughout the US will be involved in the program – details of the centers currently involved can be found here.
Idebenone, the investigational medicine used in BreatheDMD program, will be provided free-of- charge to participating patients.
Travel to participating BreatheDMD centers and other expenses incurred during your participation in this program are the responsibility of the patient and family.
Idebenone is under investigation in the US, to evaluate its safety and efficacy in DMD.
As with any investigational medication that has not been approved by the FDA, idebenone may or may not be effective in treating your DMD and there may be risks associated with its use. You will need to talk to your treating physician about the possibility and risks of taking part in the program.
Eligible US residents can receive idebenone in this program from a US practicing physician through one of the BreatheDMD center.
You and your parents/guardian should contact your treating physician about taking part in the BreatheDMD program. Your treating physician should contact the nearest BreatheDMD center and confirm your interest in participating in the program.
Your treating physician can gain further information by calling (877) 768-4303.
In order to participate in the BreatheDMD program, you will need to satisfy the following key criteria:
1. Diagnosis of DMD
2. Minimum age of 8 years old
3. Not eligible for any ongoing clinical trial of idebenone
4. Have the ability to swallow medication
5. Lung-function test - Forced Vital Capacity (FVC) or Peak Expiratory Flow (PEF) less than or equal to 80% but greater than 25% of predicted value
Additional criteria will need to be met and the participating BreatheDMD physicians will make further assessment of your suitability to enroll in the program. Unfortunately, not all patients will be able to participate.
If your participating BreatheDMD physician determines you are eligible to participate in the BreatheDMD expanded access program, you and your parent/ guardian will be asked to sign a consent form in order to take part in the BreatheDMD program. Your participating BreatheDMD physician will review the consent form with you, which will explain the responsibilities of participating in the BreathDMD program, the collection of data during the program, answer any questions you have about the program and obtain your permission to participate in the program. You can discontinue your participation in the program at any time.
Idebenone is a medicine that is under investigation for the treatment of DMD. It has not been approved by the US Food and Drug Administration (FDA) and the safety and efficacy continue to be evaluated in clinical trials.
To find your closest BreatheDMD center, roll your mouse over the map below. If your treating physician is not listed here, you may ask them to refer you to your nearest BreatheDMD center.
Call (877) 768-4303