MOUNTAIN VIEW, Calif.,
"We are pleased that these results support our previous findings of cardiac safety from our long term open label and pharmacodynamics trials," said
This trial was a randomized, double-blind, placebo-controlled, three-way, crossover trial in 54 healthy adults comparing the acute effects of a supra-therapeutic dose of LEVADEX (approximately three times the anticipated commercial dose), oral moxifloxacin (400 mg) and placebo on the cardiac QT interval as measured by electrocardiogram. Moxifloxacin is a positive control known to increase the QT interval.
For the supra-therapeutic dose of LEVADEX, the largest mean difference from placebo in QTc (using the individual correction method for heart rate, or QTci) was 0.08 milliseconds, and the largest one-sided 95% upper confidence bound was 2.24 milliseconds. The threshold level of regulatory concern is when the change produced by a drug has a 95% upper confidence bound that exceeds 10 milliseconds. The number of subjects with individual QTc intervals > 450 milliseconds and increases in QTc from baseline > 30 milliseconds were similar to placebo. Moxifloxacin, the positive control, produced QT prolongation consistent with previous thorough QT trials.
LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 development. Patients administer LEVADEX themselves using the company's proprietary TEMPO® inhaler. LEVADEX has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that LEVADEX has the potential to provide both fast onset of action, sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.
LEVADEX is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the efficacy portion of the FREEDOM-301 trial, the company believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.
Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). According to the
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