(RxWiki News) The US Food and Drug Administration (FDA) has approved the OTC switch for a migraine device.
This approval is for Cefaly Dual (Cefaly Technology). The FDA approved it to treat and prevent acute migraines in adults over the age of 18.
Once available only by prescription, this device can now be purchased over-the-counter (without a prescription).
This treatment option is considered non-invasive and does not contain any medication.
This device is known as an external trigeminal nerve stimulation device. It works to treat and prevent acute migraines by stimulating the trigeminal nerve.
This device includes an electrode that is applied to the forehead (between the eyebrows). It then sends small electrical impulses to the nerve. When using the device, it is normal to feel strange sensations like tingling.
The device actually has two settings: one setting for acute migraines and one to prevent migraines.
On different settings, the device is applied for different amounts of time:
- Acute migraines: The user will wear the device for 60 minutes at the onset of or during a migraine attack.
- Prevention of migraines: The user will wear the device for 20 minutes each day (preferably in the evening).
According to the company that makes the device, the device can be used alone or with the standard migraine treatment.
Cefaly Dual may not be for everyone. Those who have a pacemaker, defibrillator, or implanted metallic or electronic devices in the head are not recommended to use this device.
The long-term effects of ongoing use of this device are not known at this time. Before purchasing or using Cefaly Dual, ask your health care provider if this device is an option for you.
This device can be bought online starting this month. At the time of publication, the cost was $399.
The maker of this device lists the warnings and directions. These can be found on the product’s website.