The US drug regulatory agency,the FDA has approved Ubrelvy
t) 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
Dr Billy Dunn acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research told Thailand Medical
is an often disabling condition that affects an estimated 37 million people in the US. 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
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.
effectiveness 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 g
reater 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 2 hours after taking Ubrelvy
. Twenty-three percent of patients were taking a preventive medication for migraine.
Common side effects that patients in the clinical trials reported were nausea, tiredness and dry mouth. Ubrelvy
is contraindicated for co-administration with strong CYP3A4 inhibitors.
The US FDA granted the approval of Ubrelvy
to Allergan USA, Inc.