Acorda executive director of device and program management Sean Plunkett said: "CVT-427 represents an innovative approach to acute treatment of migraines. Applying Acorda’s proprietary ARCUS technology, we have developed an inhaled version of a well-established migraine therapy.
"We are excited about evaluating the potential of CVT-427 to offer a unique way to treat people with migraine who are not completely satisfied with their current options."
CVT-427 is a novel, inhaled formulation of zolmitriptan that uses the Company’s proprietary ARCUS® technology. Zolmitriptan belongs to a class of drugs known as triptans, which are a leading therapy for acute treatment of migraines. Triptans are most commonly administered orally, usually as a pill.
Oral migraine therapies can be associated with slow onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain.
Another consideration in acute treatment of migraine is nausea. It is estimated that almost 90% of people living with migraines have experienced nausea at least once during a migraine attack. Nausea and vomiting can be so debilitating that people either delay, or completely forgo, taking an oral medication; more than 50% of migraine sufferers experience this degree of nausea with the majority of their migraine attacks. Inhaled treatments, such as those that utilize the ARCUS technology, enter the body rapidly through the lungs, bypassing the digestive system.
This Phase 1 clinical trial is a single ascending dose study that is designed to enroll 32 participants. It will assess the pharmacokinetic profile, safety and tolerability of CVT-427 at four different dosages in healthy volunteers.