The U.S. Food and drug administration recently approved Ubrelvy (ubrogepant) tablets for immediate treatment of migraine in adults. The medicine can be used for patients with or without aura (a sensory or visual disturbance before the headache).
Migraine is a primary headache disorder characterized by recurring headaches that might range from moderate to severe. Typically, the headache affects one half of the head and comes with a pulsating sensation, lasting from a few hours to 3 days. Common symptoms include nausea, vomiting, and sensitivity to light, sound or even smell. The pain generally worsens with physical activity.
About one-third of the people with migraines experience an aura – a short period of visual disturbances that indicate the arrival of a headache. However, the aura doesn’t always end in excruciating pains.
Migraines are typically believed to be due to a mixture of environmental and genetic factors. About two-thirds of the cases run in families, the rest might be because of changing hormonal levels or some environmental triggers. The exact cause is not known yet.
There are several ways one can ease the pain, including:
- Resting in a quiet dark room
- Applying a hot or cold compress on your forehead or the back of your neck
- Smelling lavender
- Massaging your temples
- Staying hydrated
However, the tips don’t always have immediate effects and the patients have to sit through hours of agony and pain until they start getting better.
FDA recently approved a new treatment for the immediate relief of migraine. Ubrelvy tablets can be used for acute treatment of the pain. It is not indicated for preventative treatment of the condition though.
Ubrelvy is the first drug in the ‘oral calcitonin gene-related peptide receptor antagonists’ approved for the treatment. The effectiveness of the drug was tested in two randomized, double-blind, placebo-controlled trials. The studies involved 1439 adult patients with a history of migraine, with and without aura, who received the appropriate doses of Ubrelvy to treat the ongoing migraine.
Both studies showed that the percentage of patients who reported a reduction in the severity of the pain and the symptoms was higher with the ones that received the drug, as a comparison to those who received the placebo. The most common side effects the subjects reported were nausea, tiredness and a dry mouth.
According to Billy Dunn, M.D., acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, “Migraine is an often disabling condition that affects an estimated 37 million people in the U.S. 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. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies.”
About the U.S. Food and Drug Administration (FDA)
FDA is an agency within the US Department of Health and Human Services that is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines and medical devices. The agency also overlooks the safety and security of the nation’s food supply, cosmetics, and dietary supplements.