The U.S. Food and Drug
Administration today 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.
“Migraine is an often
disabling condition that affects an estimated 37 million people in the
U.S.,” said Billy Dunn, M.D., acting director of the Office of
Neuroscience in the FDA’s Center for Drug Evaluation and Research.
“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.”
Migraine headache pain is
often described as an intense throbbing or pulsating pain in one area
of the head. Additional symptoms include nausea and/or vomiting and
sensitivity to light and sound. Approximately one third of individuals
who suffer from migraine also experience aura shortly before the
migraine. An aura can appear as flashing lights, zig-zag lines, or a
temporary loss of vision. Migraines can often be triggered by various
factors including stress, hormone changes, bright or flashing lights,
lack of food or sleep and diet. Migraine is three times more common in
women than in men and affects more than 10% of people worldwide.
The
effectiveness of Ubrelvy for the acute treatment of migraine was
demonstrated in two randomized, double-blind, placebo-controlled trials.
In these studies, 1,439 adult patients with a history of migraine, with
and without aura, received the approved doses of Ubrelvy to treat an
ongoing migraine. In both studies, the percentages of patients achieving
pain freedom two hours after treatment (defined as a reduction in
headache severity from moderate or severe pain to no pain) and whose
most bothersome migraine symptom (nausea, light sensitivity or sound
sensitivity) stopped two hours after treatment were significantly
greater among patients receiving Ubrelvy at all doses compared to those
receiving placebo. Patients were allowed to take their usual acute
treatment of migraine at least two hours after taking Ubrelvy. 23% of
patients were taking a preventive medication for migraine.
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