SUD-001 | Oral spray for migraine
SUD-001 is first oral spray of sumatriptan (GSK’s Imitrex® tablet) for rapid relief of migraine headache
Migraine market is approx $3.2 billion. Sumatriptan has 50% market share Phase II study showed quicker onset of action and less drug needed to achieve pain relief vs. Imitrex tablet
Primary Market Research suggests prescribers & payers see important role for SUD-001 in patients with nausea, GI problems or sudden onset headaches
Successful meeting with FDA in 2015 regarding pivotal development plan - FDA accepted novel pharmacokinetic trial design, thus avoiding the need for costly efficacy studies prior to approval
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