The US Food and Drug Administration (FDA) has declined approval for an orally inhaled formulation of dihydroergotamine (DHE; Levadex, Allergan Inc) for acute treatment of migraine in adults.
The hope for the new formulation of DHE, which is already available as an intravenous agent and as an intranasal treatment (Migranal, Valeant Pharmaceuticals), is to provide a rapid onset of action and sustained pain relief with fewer adverse effects compared with intravenous administration.
This FDA approval application was based on phase 3 findings from the multicenter, randomized, double-blind, placebo-controlled phase 3 trial, FREEDOM-301, reported previously by Medscape Medical News. The trial met all 4 primary endpoints of relief of pain, phonophobia, and photophobia and freedom from nausea at 2 hours. The study was funded by MAP Pharmaceuticals Inc, which developed the Tempo inhaler to deliver the drug, and was acquired by Allergan Inc earlier this year.
The drug showed rapid and sustained efficacy, was well tolerated with minimal adverse effects, and produced a low incidence of triptan-like sensations. It also appeared effective in patients generally thought to be treatment-resistant. The most common adverse event was medication aftertaste, reported in 6% of the treatment group but also in 2% of placebo-treated patients. There were no decreases in lung function
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