There is hope for folks suffering from migraine headache as FDA approves new drug for migraine headaches, reports coming in states that the U.S. Food and Drug Administration had on Monday approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults.
Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.
The drug will be sold under the name Ubrelvy by the pharmaceutical company Allergan. It is considered effective for migraine with or without aura, referring to the sensory or visual disturbances that occur among roughly a third of migraine sufferers.
Causes Of Migraine Headaches:
Migraine headaches are a symptom of an overall condition known as migraine. Doctors don’t know the exact cause of migraine headaches, although they seem to be related to changes in the brain as well as to genes that run in families. You can even inherit the triggers that give you migraine headaches, like fatigue, bright lights, weather changes, and others.
For many years, scientists believed migraines resulted from changes in blood flow in the brain. Many now think that they happen because of flaws in the brain passed down from your parents.
A migraine starts when overactive nerve cells send out signals that activate the trigeminal nerve, the nerve that supplies sensation to your head and face. Activation of the nerve causes the release of certain chemicals like serotonin and calcitonin gene-related peptide (CGRP). CGRP causes blood vessels in the lining of the brain to swell. This releases neurotransmitters that create inflammation and pain.
Statistics On Sufferers:
An estimated 40 million Americans and 1 billion people worldwide suffer from migraines. The condition affects 1 in 5 women and 1 in 16 men, according to the American migraine foundation. The most common symptom is an intense headache typically affecting one side of the brain, but symptoms can also include nausea, vomiting, and light, noise and smell sensitivity. The onset of a migraine can involve visual disturbances known as auras.
Migraines, which often begin in childhood, adolescence or early adulthood, can progress through four stages: prodrome, aura, attack and post-drome. Not everyone who has migraines goes through all stages.
One or two days before a migraine, you might notice subtle changes that warn of an upcoming migraine, including:
- Mood changes, from depression to euphoria
- Food cravings
- Neck stiffness
- Increased thirst and urination
- Frequent yawning
Migraine Headache Aura:
For some people, aura might occur before or during migraines. Auras are reversible symptoms of the nervous system. They’re usually visual but can also include other disturbances. Each symptom usually begins gradually, builds up over several minutes and lasts for 20 to 60 minutes.
Examples of migraine aura include:
- Visual phenomena, such as seeing various shapes, bright spots or flashes of light
- Vision loss
- Pins and needles sensations in an arm or leg
- Weakness or numbness in the face or one side of the body
- Difficulty speaking
- Hearing noises or music
A migraine usually lasts from four to 72 hours if untreated. How often migraines occur varies from person to person. Migraines might occur rarely or strike several times a month.
During a migraine, you might have:
- The pain usually on one side of your head, but often on both sides
- Pain that throbs or pulses
- Sensitivity to light, sound, and sometimes smell and touch
- Nausea and vomiting…
The Good News From FDA:
In a study published last month, the drug showed greater rates of pain and symptom relief from migraine compared to a placebo, with more than 19% of participants given the drug reporting to be pain-free within two hours and nearly 40% relieved of the most bothersome symptoms linked to migraine, which include light and noise sensitivity. This is compared to roughly 12% and 28%, respectively, from the placebo. Nausea, sleepiness and dry mouth were the most commonly reported side effects.
“Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication,” Dr Billy Dunn, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement on Monday.