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Pulmatrix Announces Positive Top Line Results In Phase 1 Study With PUR3100 For Acute Migraine
(RTTNews) - Biopharmaceutical company Pulmatrix, Inc. (PULM) announced Wednesday the successful completion of a Phase 1 trial evaluating safety and pharmacokinetics of PUR3100 in healthy volunteers for the treatment of acute migraine.
PUR3100 uses the Company's iSPERSE formulation technology to create an orally inhaled dry powder formulation of dihydroergotamine (DHE) to treat acute migraine.
The Phase 1 trial, performed at Nucleus Network in Melbourne, Australia, was a double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups of inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. Twenty-six healthy subjects were enrolled and each of the four groups contained at least six subjects.
PUR3100 was well-tolerated and there was a lower incidence of nausea in PUR3100 dose groups compared to IV DHE.
Dose selection is underway for the Phase 2 study and an FDA meeting will be requested this month.
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